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Most recent job postings at pharma iq
via Paylocity
schedule_type: Full-time
Description
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating
Description
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained. Involvement in new product formulation, scale-up process optimization, process validation and technology transfers. Participates in the timely manufacture of supplies in support of clinical and stability programs.
JOB DUTIES & RESPONSIBILITIES
• Independently assists in formulation work in early stage research
• Oversees and coordinates development manufacturing events
• Operate general processing equipment/analytical instruments during formulation work, such as Granulator, Dryer, Blender, Tablet coater, Fluid Bed coating, HPLC, pH meter, viscometer, particle size testing etc. or any processing equipment as needed for the project.
• Perform IQ/OQ for all the equipment as needed
• Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures.
• Responsible for the design and development of products and process used in manufacturing from small-scale manufacturing to commercial operation.
• Analyzes and interprets protocol an experimental data to set product and process specifications.
• Analyzes existing equipment and recommends modifications when necessary for process optimization
• Presents test data and findings to management as required.
• Trains small scale- up manufacturing personnel as required
• Ability to lift up to 50 pounds.
Requirements
Minimum Education & Experience:
• Bachelor’s or Master’s degree in engineering or a related field from an accredited college or university.
• At least 2 or more years of experience in designing products/processes and installing operating and troubleshooting equipment in pharmaceutical manufacturing equipment (or food, or cosmetic manufacturing environment, or an equivalent combination of training and experience.
Required Knowledge & Skills:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
• Drug Enforcement Agency (DEA) and other regulatory requirements.
• Engineering principles applied to the manufacturing process including mixing, coating, die-cutting, pouching, and filling processes.v
• Pharmaceutical quality control and manufacturing processes.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation.
• Personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
• Statistical process control Show more details...
Under general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing... processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained. Involvement in new product formulation, scale-up process optimization, process validation and technology transfers. Participates in the timely manufacture of supplies in support of clinical and stability programs.
JOB DUTIES & RESPONSIBILITIES
• Independently assists in formulation work in early stage research
• Oversees and coordinates development manufacturing events
• Operate general processing equipment/analytical instruments during formulation work, such as Granulator, Dryer, Blender, Tablet coater, Fluid Bed coating, HPLC, pH meter, viscometer, particle size testing etc. or any processing equipment as needed for the project.
• Perform IQ/OQ for all the equipment as needed
• Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures.
• Responsible for the design and development of products and process used in manufacturing from small-scale manufacturing to commercial operation.
• Analyzes and interprets protocol an experimental data to set product and process specifications.
• Analyzes existing equipment and recommends modifications when necessary for process optimization
• Presents test data and findings to management as required.
• Trains small scale- up manufacturing personnel as required
• Ability to lift up to 50 pounds.
Requirements
Minimum Education & Experience:
• Bachelor’s or Master’s degree in engineering or a related field from an accredited college or university.
• At least 2 or more years of experience in designing products/processes and installing operating and troubleshooting equipment in pharmaceutical manufacturing equipment (or food, or cosmetic manufacturing environment, or an equivalent combination of training and experience.
Required Knowledge & Skills:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
• Drug Enforcement Agency (DEA) and other regulatory requirements.
• Engineering principles applied to the manufacturing process including mixing, coating, die-cutting, pouching, and filling processes.v
• Pharmaceutical quality control and manufacturing processes.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation.
• Personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
• Statistical process control Show more details...
via ZipRecruiter
posted_at: 2 days agoschedule_type: Full-time
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Quality Engineer
Location: Chelmsford, MA - 01824
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 08:00 AM to 05:00 PM
Job Summary:
• As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility by acting as a Quality Engineering subject matter expert.
• You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions.
• You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
• Investigate process/product deviations and out-of-specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys etc.
• Ensure DEA compliance and act as a CSP coordinator
• Handle customer complaints with professionalism and efficacy.
• Troubleshoot electrodes and buffer solutions.
• Implement corrective and preventative actions (CAPAs) to prevent the recurrence of deviations and nonconformances.
• Verify the effectiveness of implemented changes utilizing the proper quality tools.
• Guide the disposition of non-conforming material (final product and raw material).
• Perform statistical analysis to monitor process and product performance and react to negative trends.
• Lead change controls for complex improvement projects utilizing risk-based methodologies.
• Have expert knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
• Lead and generate risk assessments (product and process- FMEAs).
• Have strong knowledge of process, product, and equipment validation principles (i.e. IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
• Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
• Drives for continuous improvements in all areas supports improvement efforts, implements changes, and verifies effectiveness of changes.
• Support internal and external audits, customer audits, and supplier audits.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Write or revise standard quality control operating procedures and quality system documentation as required.
• Write technical reports such as investigation summary reports and change management records.
Requirements Knowledge - Skills:
• Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline.
• Graduate degree (MS) is also a plus.
• A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
• Proven experience with titrators and PH testing
• Strong verbal and written communication skills in English.
• Ability in technical and statistical writing.
• Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
• Ability to work in a matrix organization.
• A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Strong analytical, problem-resolution, judgment, and decision-making skills
• Operation requires the use of safety equipment including but not limited to safety glasses and safety gloves.
• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions.
• Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.
• Demonstrated validation proficiency, with knowledge of product, process, and equipment qualifications and validations (IQ/OQ/PQ).
• Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
• Lean Sigma Green or Black Belt certification is a plus.
• ASQ CQE is a plus.
• Excellent organization skills with strong attention to detail.
• Ability to multitask efficiently to support production demand.
• Computer skills: knowledge of Microsoft Office applications (Word, Excel, and PowerPoint) is a must.
TekWissen Group is an equal-opportunity employer supporting workforce diversity Show more details...
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the... global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Quality Engineer
Location: Chelmsford, MA - 01824
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 08:00 AM to 05:00 PM
Job Summary:
• As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility by acting as a Quality Engineering subject matter expert.
• You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions.
• You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
• Investigate process/product deviations and out-of-specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys etc.
• Ensure DEA compliance and act as a CSP coordinator
• Handle customer complaints with professionalism and efficacy.
• Troubleshoot electrodes and buffer solutions.
• Implement corrective and preventative actions (CAPAs) to prevent the recurrence of deviations and nonconformances.
• Verify the effectiveness of implemented changes utilizing the proper quality tools.
• Guide the disposition of non-conforming material (final product and raw material).
• Perform statistical analysis to monitor process and product performance and react to negative trends.
• Lead change controls for complex improvement projects utilizing risk-based methodologies.
• Have expert knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
• Lead and generate risk assessments (product and process- FMEAs).
• Have strong knowledge of process, product, and equipment validation principles (i.e. IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
• Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
• Drives for continuous improvements in all areas supports improvement efforts, implements changes, and verifies effectiveness of changes.
• Support internal and external audits, customer audits, and supplier audits.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Write or revise standard quality control operating procedures and quality system documentation as required.
• Write technical reports such as investigation summary reports and change management records.
Requirements Knowledge - Skills:
• Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline.
• Graduate degree (MS) is also a plus.
• A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
• Proven experience with titrators and PH testing
• Strong verbal and written communication skills in English.
• Ability in technical and statistical writing.
• Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
• Ability to work in a matrix organization.
• A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Strong analytical, problem-resolution, judgment, and decision-making skills
• Operation requires the use of safety equipment including but not limited to safety glasses and safety gloves.
• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions.
• Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.
• Demonstrated validation proficiency, with knowledge of product, process, and equipment qualifications and validations (IQ/OQ/PQ).
• Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
• Lean Sigma Green or Black Belt certification is a plus.
• ASQ CQE is a plus.
• Excellent organization skills with strong attention to detail.
• Ability to multitask efficiently to support production demand.
• Computer skills: knowledge of Microsoft Office applications (Word, Excel, and PowerPoint) is a must.
TekWissen Group is an equal-opportunity employer supporting workforce diversity Show more details...
via Careers | Engineering Resource Group - TerkoTech
schedule_type: Full-timesalary: 90K–110K a year
Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing
Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
Coordinate the efforts of the personnel involved during on-site qualification.
Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
Develop, maintain, and enhance positive interpersonal relationships with staff members. BS Engineering or Science
Minimum 5 years of related experience.
Must posses a valid driver's license.
Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
Must have the ability to develop validation protocol (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail asre essential.
Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
Must be willing and be capable to climb ladders and to enter restrictive spaces.
Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part Show more details...
Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
Work with company's control system programmers to develop and execute factory acceptance software test documents...
Work as an integral member of a project team.
Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
Coordinate the efforts of the personnel involved during on-site qualification.
Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
Develop, maintain, and enhance positive interpersonal relationships with staff members. BS Engineering or Science
Minimum 5 years of related experience.
Must posses a valid driver's license.
Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
Must have the ability to develop validation protocol (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail asre essential.
Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
Must be willing and be capable to climb ladders and to enter restrictive spaces.
Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part Show more details...
via LinkedIn
schedule_type: Full-time
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider. Aavis Pharmaceuticals. We currently have an exciting opportunity available for a Validation Specialist .
The Validation Specialist is responsible for the development of the formulation for various pharmaceutical products. The Validation... Specialist actively participates in all the phases of the
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider. Aavis Pharmaceuticals. We currently have an exciting opportunity available for a Validation Specialist .
The Validation Specialist is responsible for the development of the formulation for various pharmaceutical products. The Validation... Specialist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.
Key Responsibilities Include But Are Not Limited To
• The Validation Specialist will perform installation, operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems such as planning, coordination, development, execution and close out of qualification and/or validation protocols/reports meeting quality and schedule expectations
Additional responsibilities include but are not limited to: support cleaning development activities, creation of standard operating procedure, provide technical training, audit GMP documentation, investigation, Gap/Risk assessments and troubleshooting and/or providing recommendation to resolve issues or to optimize qualification activities, As needed, the position will also support the cleaning validation, verification activities
This includes FAT/SAT, URS, FRS, DQ, Risk Assessments, IQ, OQ/PQ, and other validation life cycle documents
Assist in cleaning validation activities at the site, which includes development of validation protocols, testing execution and closure of validation reports
Follow GDP practices while developing qualification packages
Assists with the site change management program to keep the equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings
Stay current with industry qualification trend through FDA, ISPE, EU PDA and bench mark with industry standards
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Other duties as assigned.
Qualifications And Requirement
• Bachelor degree in relevant scientific discipline or equivalent required
3+ years of experience in pharmaceutical or any regulated industry, A combination of education and relevant experience will be considered
Understanding of validation and qualification principles, and quality system principles (change control, non-conformance and CAPA)
Knowledge of cGMP, FDA Regulations, WHO standards, ICH-Q8, Q9 and Q10, and other applicable industry regulations and standards
Ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations/engineering staff
Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria
Working experience qualifying any of the OSD/Sterile Manufacturing and Packaging equipment, facilities and utilities
Legal authorization to work in the US is required
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more Show more details...
The Validation Specialist is responsible for the development of the formulation for various pharmaceutical products. The Validation... Specialist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.
Key Responsibilities Include But Are Not Limited To
• The Validation Specialist will perform installation, operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems such as planning, coordination, development, execution and close out of qualification and/or validation protocols/reports meeting quality and schedule expectations
Additional responsibilities include but are not limited to: support cleaning development activities, creation of standard operating procedure, provide technical training, audit GMP documentation, investigation, Gap/Risk assessments and troubleshooting and/or providing recommendation to resolve issues or to optimize qualification activities, As needed, the position will also support the cleaning validation, verification activities
This includes FAT/SAT, URS, FRS, DQ, Risk Assessments, IQ, OQ/PQ, and other validation life cycle documents
Assist in cleaning validation activities at the site, which includes development of validation protocols, testing execution and closure of validation reports
Follow GDP practices while developing qualification packages
Assists with the site change management program to keep the equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings
Stay current with industry qualification trend through FDA, ISPE, EU PDA and bench mark with industry standards
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Other duties as assigned.
Qualifications And Requirement
• Bachelor degree in relevant scientific discipline or equivalent required
3+ years of experience in pharmaceutical or any regulated industry, A combination of education and relevant experience will be considered
Understanding of validation and qualification principles, and quality system principles (change control, non-conformance and CAPA)
Knowledge of cGMP, FDA Regulations, WHO standards, ICH-Q8, Q9 and Q10, and other applicable industry regulations and standards
Ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations/engineering staff
Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria
Working experience qualifying any of the OSD/Sterile Manufacturing and Packaging equipment, facilities and utilities
Legal authorization to work in the US is required
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more Show more details...
via LinkedIn
schedule_type: Full-time
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider. Aavis Pharmaceuticals. We currently have an exciting opportunity available for a Formulation Scientist .
The Formulation Scientist is responsible for the development of the formulation for various pharmaceutical products. The Formulation... Scientist actively participates in all the phases of the
If you are looking for a dynamic, innovative, growing company in the pharmaceutical industry that is committed to excellence and integrity, then consider. Aavis Pharmaceuticals. We currently have an exciting opportunity available for a Formulation Scientist .
The Formulation Scientist is responsible for the development of the formulation for various pharmaceutical products. The Formulation... Scientist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.
Key Responsibilities Include But Are Not Limited To
• Responsible for developing various pharmaceutical products leading to successful NDA/ANDA filings and approval in a timely manner through internal or external sources.
• Responsible for handling multiple projects, prioritizing activities to meet the milestones in a fast pace environment.
• Responsible for reviewing literature and patents and work on the technical approaches for pharmaceutical/ ANDA product development.
• Designing and conducting experiments for pre-formulation, formulation/process development, scale-up for various drug dosage forms by following appropriate GMP regulations and safety requirements.
• Responsible for execution of Registration batches and technology-transfer/ process development batches.
• Responsible for preparation / review of product batch records and protocols for different product development stages, including from R&D prototype formulation, scale-up to process validation by following related SOPs and procedures, ensuring the detailed record and data keeping.
• Responsible for characterization of API, excipients, compatibility studies, conduct formulation trials, compile & review data to support successful development.
• Supporting R&D function, select proper equipment for various dosage form product development; developing SOPs and technical documents to support IQ/OQ/PQ processes of equipment.
• Ensure all equipment is in a good condition to safely and effectively conduct product development experiments in a timely manner; maintaining formulation Lab in a clean and safe working environment.
• Write / record development work and draft technical reports to support product development, specifications, and stability in NDAs/ANDA and other regulatory submissions.
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Other duties as assigned.
Qualifications And Requirement
• Master’s degree in Pharmaceutical Sciences or related discipline.
• At least 2 years relevant work experience in Generic/ ANDA pharmaceutical product development.
• In-depth theoretical and hands on experience in pharmaceutical technologies and equipment for various dosage forms (mainly oral solids like tablets, capsules etc.), including sustained release (MR/DR) formulations.
• May handle hazardous materials and may require wearing personal protective equipment as needed
• Must be able to move about the laboratory and the facility
• Must be able to remain in an upright position for periods of time.
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more Show more details...
The Formulation Scientist is responsible for the development of the formulation for various pharmaceutical products. The Formulation... Scientist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.
Key Responsibilities Include But Are Not Limited To
• Responsible for developing various pharmaceutical products leading to successful NDA/ANDA filings and approval in a timely manner through internal or external sources.
• Responsible for handling multiple projects, prioritizing activities to meet the milestones in a fast pace environment.
• Responsible for reviewing literature and patents and work on the technical approaches for pharmaceutical/ ANDA product development.
• Designing and conducting experiments for pre-formulation, formulation/process development, scale-up for various drug dosage forms by following appropriate GMP regulations and safety requirements.
• Responsible for execution of Registration batches and technology-transfer/ process development batches.
• Responsible for preparation / review of product batch records and protocols for different product development stages, including from R&D prototype formulation, scale-up to process validation by following related SOPs and procedures, ensuring the detailed record and data keeping.
• Responsible for characterization of API, excipients, compatibility studies, conduct formulation trials, compile & review data to support successful development.
• Supporting R&D function, select proper equipment for various dosage form product development; developing SOPs and technical documents to support IQ/OQ/PQ processes of equipment.
• Ensure all equipment is in a good condition to safely and effectively conduct product development experiments in a timely manner; maintaining formulation Lab in a clean and safe working environment.
• Write / record development work and draft technical reports to support product development, specifications, and stability in NDAs/ANDA and other regulatory submissions.
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Other duties as assigned.
Qualifications And Requirement
• Master’s degree in Pharmaceutical Sciences or related discipline.
• At least 2 years relevant work experience in Generic/ ANDA pharmaceutical product development.
• In-depth theoretical and hands on experience in pharmaceutical technologies and equipment for various dosage forms (mainly oral solids like tablets, capsules etc.), including sustained release (MR/DR) formulations.
• May handle hazardous materials and may require wearing personal protective equipment as needed
• Must be able to move about the laboratory and the facility
• Must be able to remain in an upright position for periods of time.
WHY SHOULD YOU WORK WITH AAVIS?
Competitive Pay
Medical, Vision, Dental insurance benefits
Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )
401k Benefits with 4% company match
Front Loaded PTO Days
Company wide recreational events
Free snacks
Paid Maternity/Paternity leaves
Amazing Advancement opportunities
So much more Show more details...
via Working At Sun Pharma
posted_at: 4 days agoschedule_type: Full-time
Job Summary
Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology...
Area Of Responsibility
• QC Testing data review of products, raw materials, stability lots
• Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system
• Plan, direct and coordinate QC batch record review,
Job Summary
Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology...
Area Of Responsibility
• QC Testing data review of products, raw materials, stability lots
• Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system
• Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities
• Support any regulatory inspections or internal/external audits
• Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products
• Conduct, document and follow up on OOS and OOT and Out of Calibration investigations
• Conduct, document and follow up on Lab Events
• Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
• Review IQ/OQ and PQ protocols for analytical instruments
• Maintain laboratory in cGMP compliance and conduct inspections and internal audits
• Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
• Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company
• Any Other duties as assigned
Work Conditions:
• Office
• Lab
• Noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
• Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials.
• Exposure to or use of syringes and needles
Physical Requirements:
• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 10 lbs.
• Operates Computer/office machines
Travel Estimate
Up to 5%
Education and Job Qualification
• B.S. or equivalent experience
• Excellent oral, written and interpersonal communication skills
• Ability to follow specific instruction (i.e. written SOPs)
Experience:
• Minimum 5-7 years of related experience
• Working knowledge of cGMP/GLP
• Fundamental knowledge of chemical principles and analytical instrumentation
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
• Competent computer skills including Microsoft Office and instrumentation control software programs
• Experience with qualitative and quantitative analysis using good analytical laboratory practices
• Proficient in use of Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter,, pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral Show more details...
Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology...
Area Of Responsibility
• QC Testing data review of products, raw materials, stability lots
• Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system
• Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities
• Support any regulatory inspections or internal/external audits
• Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products
• Conduct, document and follow up on OOS and OOT and Out of Calibration investigations
• Conduct, document and follow up on Lab Events
• Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
• Review IQ/OQ and PQ protocols for analytical instruments
• Maintain laboratory in cGMP compliance and conduct inspections and internal audits
• Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
• Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company
• Any Other duties as assigned
Work Conditions:
• Office
• Lab
• Noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
• Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials.
• Exposure to or use of syringes and needles
Physical Requirements:
• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 10 lbs.
• Operates Computer/office machines
Travel Estimate
Up to 5%
Education and Job Qualification
• B.S. or equivalent experience
• Excellent oral, written and interpersonal communication skills
• Ability to follow specific instruction (i.e. written SOPs)
Experience:
• Minimum 5-7 years of related experience
• Working knowledge of cGMP/GLP
• Fundamental knowledge of chemical principles and analytical instrumentation
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
• Competent computer skills including Microsoft Office and instrumentation control software programs
• Experience with qualitative and quantitative analysis using good analytical laboratory practices
• Proficient in use of Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter,, pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral Show more details...
via Talent.com
posted_at: 2 days agoschedule_type: Full-timesalary: 108K–132K a year
The Manager, Digital Media for Alchemee (including the Proactiv brand) will be responsible for owning the consumer experience part of the digital media / marketing function.
Secondarily, this role will assist in implementing, analyzing, reporting and optimizing that experience via paid digital media plans in the US and Canada...
This analytical leader will leverage multiple digital channels including paid search (e.g. Google, Bing), social media
The Manager, Digital Media for Alchemee (including the Proactiv brand) will be responsible for owning the consumer experience part of the digital media / marketing function.
Secondarily, this role will assist in implementing, analyzing, reporting and optimizing that experience via paid digital media plans in the US and Canada...
This analytical leader will leverage multiple digital channels including paid search (e.g. Google, Bing), social media (e.
g. Meta, TikTok, Pinterest) and programmatic display to ensure consumer touchpoints are optimized via full funnel campaigns at scale.
Manager will partner with media and marketing as well as brand to understand target audiences, position bran, develop strategies, and implement campaigns to increase conversion and sales with optimal website UX.
Duties and responsibilities :
• Partner with marketing team to develop holistic cross-channel marketing strategies to build a cohesive customer journey across paid, owned and earned channels, conceptualizing user flow, user experience on website(s) US and Canada
• Develop, execute and optimize the brand(s) digital paid media strategies as part of the broader business growth strategy, including paid search, programmatic, paid social including testing and growing new, relevant digital channels
• Collaborate with brand, product management, offer and creative teams to develop and test relevant ads and landing page content for various consumer segments.
Conduct A / B testing as needed to optimize KPIs (e.g. CTR, Engagement, CVR)
• Forecast performance and budget appropriately to deliver reliable results.
• Leverage analytics tools and key insights to optimize plans and creative; conduct content audits to eliminate redundant / old information and data.
• Communicate and implement content updates accurately and in a timely manner.
• Develop and maintain productive relationships with internal and external stakeholders across the organization.
• Form a strong relationship with the internal content team, as well as manage and drive digital specific external creative agencies to ensure each campaign has required assets.
• Stay relevant in digital innovations, competitive environment and overall macro trends
• Maintain regular communication regarding KPIs and relevant learnings with executive leadership team and senior marketing executives
• Responsible for overall DTC website management, US and Canada, including all owned properties / landing pages.
• Develop merchandising strategies that deliver optimal consumer experience while hitting financial goals across though DTC subscription and singe order sales.
• Other duties as assigned.
Qualifications :
• BS / BA degree in marketing, communications or related field, required
• 5-8 years of digital media planning / buying experience, with extensive experience in paid social is required
• Thorough understanding of Direct Response digital marketing, with expert knowledge of optimization tactics, and KPI management for online / digital media
• Ample experience managing external agencies
• Creative thinker with the ability and passion for understanding the customer needs and delivering them through the entire acquisition funnel
• Deep understanding of both multi-touch attribution and A / B testing models and how to optimize channels for best results.
• Thorough understanding of marketing technology (tools & tech) including analytic packages, DMP’s, Ad Servers, search platforms and data onboarding solutions.
Visual IQ experience a bonus)
• Demonstrated experience developing cutting edge strategies and leading their cross-functional implementation through an organization
• Strong analytical skills, intuitive grasp of data
• Proficiency in MS Office including Excel and PowerPoint
• Outstanding communication skills both written and spoken
• Experience generating and executing new marketing ideas for all digital channels.
• Experience with forecasting and budgeting for marketing campaigns
• High level of detail with strong attention to follow-through, and the ability to prioritize and execute many tasks while meeting strict deadlines
• Ability to identify key market trends and translate data into ideas
• Experience working with development teams to execute web projects SCRUM experience preferred
• Takes direction well; can work independently in most situations
• Reliable, dependable, works with a sense of urgency
• Enthusiastic and genuinely interested in digital marketing trends
• Consistently demonstrates the highest standards of integrity and professional conduct
The presently-anticipated base compensation pay range for this position is $107,500 to $131,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage;
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department / team performance, and market factors.
Last updated : 2024-06-13 Show more details...
Secondarily, this role will assist in implementing, analyzing, reporting and optimizing that experience via paid digital media plans in the US and Canada...
This analytical leader will leverage multiple digital channels including paid search (e.g. Google, Bing), social media (e.
g. Meta, TikTok, Pinterest) and programmatic display to ensure consumer touchpoints are optimized via full funnel campaigns at scale.
Manager will partner with media and marketing as well as brand to understand target audiences, position bran, develop strategies, and implement campaigns to increase conversion and sales with optimal website UX.
Duties and responsibilities :
• Partner with marketing team to develop holistic cross-channel marketing strategies to build a cohesive customer journey across paid, owned and earned channels, conceptualizing user flow, user experience on website(s) US and Canada
• Develop, execute and optimize the brand(s) digital paid media strategies as part of the broader business growth strategy, including paid search, programmatic, paid social including testing and growing new, relevant digital channels
• Collaborate with brand, product management, offer and creative teams to develop and test relevant ads and landing page content for various consumer segments.
Conduct A / B testing as needed to optimize KPIs (e.g. CTR, Engagement, CVR)
• Forecast performance and budget appropriately to deliver reliable results.
• Leverage analytics tools and key insights to optimize plans and creative; conduct content audits to eliminate redundant / old information and data.
• Communicate and implement content updates accurately and in a timely manner.
• Develop and maintain productive relationships with internal and external stakeholders across the organization.
• Form a strong relationship with the internal content team, as well as manage and drive digital specific external creative agencies to ensure each campaign has required assets.
• Stay relevant in digital innovations, competitive environment and overall macro trends
• Maintain regular communication regarding KPIs and relevant learnings with executive leadership team and senior marketing executives
• Responsible for overall DTC website management, US and Canada, including all owned properties / landing pages.
• Develop merchandising strategies that deliver optimal consumer experience while hitting financial goals across though DTC subscription and singe order sales.
• Other duties as assigned.
Qualifications :
• BS / BA degree in marketing, communications or related field, required
• 5-8 years of digital media planning / buying experience, with extensive experience in paid social is required
• Thorough understanding of Direct Response digital marketing, with expert knowledge of optimization tactics, and KPI management for online / digital media
• Ample experience managing external agencies
• Creative thinker with the ability and passion for understanding the customer needs and delivering them through the entire acquisition funnel
• Deep understanding of both multi-touch attribution and A / B testing models and how to optimize channels for best results.
• Thorough understanding of marketing technology (tools & tech) including analytic packages, DMP’s, Ad Servers, search platforms and data onboarding solutions.
Visual IQ experience a bonus)
• Demonstrated experience developing cutting edge strategies and leading their cross-functional implementation through an organization
• Strong analytical skills, intuitive grasp of data
• Proficiency in MS Office including Excel and PowerPoint
• Outstanding communication skills both written and spoken
• Experience generating and executing new marketing ideas for all digital channels.
• Experience with forecasting and budgeting for marketing campaigns
• High level of detail with strong attention to follow-through, and the ability to prioritize and execute many tasks while meeting strict deadlines
• Ability to identify key market trends and translate data into ideas
• Experience working with development teams to execute web projects SCRUM experience preferred
• Takes direction well; can work independently in most situations
• Reliable, dependable, works with a sense of urgency
• Enthusiastic and genuinely interested in digital marketing trends
• Consistently demonstrates the highest standards of integrity and professional conduct
The presently-anticipated base compensation pay range for this position is $107,500 to $131,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage;
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department / team performance, and market factors.
Last updated : 2024-06-13 Show more details...
via Glassdoor
posted_at: 1 month agoschedule_type: Full-timesalary: 55K–60K a year
Microbiologist, QC Microbiology
Status: Full Time Employee...
Overview:
This position is responsible for microbiological cGMP testing of sterile products developed and manufactured at American Injectables. This includes routine microbiological testing of products for release and stability (i.e., microbial enumeration, endotoxin, sterility, antimicrobial effectiveness, and microbial identification), development and validation of microbiological
Microbiologist, QC Microbiology
Status: Full Time Employee...
Overview:
This position is responsible for microbiological cGMP testing of sterile products developed and manufactured at American Injectables. This includes routine microbiological testing of products for release and stability (i.e., microbial enumeration, endotoxin, sterility, antimicrobial effectiveness, and microbial identification), development and validation of microbiological methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.
The Microbiologist performs the release and stability testing of manufactured products and works closely with manufacturing to support operations and manufacturing processes.
Responsibilities:
• Use microbiological equipment and techniques for testing such as sterility, endotoxin, microbial identification, antimicrobial effectiveness testing, and microbial enumeration while under minimal supervision.
• Perform routine and qualification testing of raw materials and product for release and stability; author qualification reports and technical methods summarizing test results. Testing and associated documentation is performed and reviewed in a timely manner with high accuracy and reliability.
• Ensure laboratory operations in support of microbiological testing is maintained such as making media, performing growth promotion, preparing working organism cultures, sterilizing materials, maintaining supplies.
• Perform environmental monitoring of the sterility suite and aseptic fill suite during static and dynamic conditions.
• Promptly report alert and/or action limit events to the appropriate personnel.
• The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies.
• Peer review of laboratory notebooks for accuracy and compliance to microbiological methods.
• Revise standard operating procedures (SOPs) for the microbiology laboratory; revisions may be related to procedural improvements, customer requests and/or audit observations.
• Perform investigations; write problem reports prior to QA review; write and complete deviations and Corrective and Preventative Actions (CAPAs); interact with customers as needed.
• Maintain accurate inventory and tracking records of supplies and equipment; Revise, review, and execute IQ/OQ/PQ protocols on laboratory equipment; Troubleshoot and make minor repairs to laboratory equipment; Ensure good housekeeping and maintain benches, laboratory, and supply rooms in a clean and orderly manner in accordance with cGMP’s, USP and FDA requirements.
• Interact with other departments, including quality assurance and production, to ensure a smooth overall workflow.
• Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards.
• Other duties as assigned by management.
Qualifications:
Required Skills/Abilities:
• Knowledge of current USP standards
• Knowledge of microbiological laboratory techniques
• Experience with microbiological instrumentation
• Ability to learn new laboratory equipment and techniques
• Excellent verbal and written communication skills
• Microbiological reasoning, root cause analysis and problem solving
• Technical writing: write, read, understand, and interpret technical writing and instructions
• MS Office skills; particularly Word and Excel
• Math and calculation skills
• Multitask and coordinate with operations and quality assurance simultaneously
• Work with a wide range of people to solve problems and resolve issues
• Work in a fast-paced environment
• Ability to maintain flexible task schedule and workflow
• Highly detail oriented with good record keeping skills
• Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team
Education/Experience:
• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry
• Minimum of 2 years related experience in quality control cGMP laboratory supporting sterile pharmaceutical manufacturing
Physical Requirements:
• Lift up to 35 lbs.
• Ability to work standing in a laboratory for an 8-hour shift
• Ability to successfully gown and work in ISO 5 environment
Training:
• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
Job Type: Full-time
Pay: $55,000.00 - $60,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance
Schedule:
• 8 hour shift
Education:
• Bachelor's (Required)
Experience:
• QC cGMP lab supporting sterile pharma manufacturing: 2 years (Required)
Work Location: In person Show more details...
Status: Full Time Employee...
Overview:
This position is responsible for microbiological cGMP testing of sterile products developed and manufactured at American Injectables. This includes routine microbiological testing of products for release and stability (i.e., microbial enumeration, endotoxin, sterility, antimicrobial effectiveness, and microbial identification), development and validation of microbiological methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.
The Microbiologist performs the release and stability testing of manufactured products and works closely with manufacturing to support operations and manufacturing processes.
Responsibilities:
• Use microbiological equipment and techniques for testing such as sterility, endotoxin, microbial identification, antimicrobial effectiveness testing, and microbial enumeration while under minimal supervision.
• Perform routine and qualification testing of raw materials and product for release and stability; author qualification reports and technical methods summarizing test results. Testing and associated documentation is performed and reviewed in a timely manner with high accuracy and reliability.
• Ensure laboratory operations in support of microbiological testing is maintained such as making media, performing growth promotion, preparing working organism cultures, sterilizing materials, maintaining supplies.
• Perform environmental monitoring of the sterility suite and aseptic fill suite during static and dynamic conditions.
• Promptly report alert and/or action limit events to the appropriate personnel.
• The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies.
• Peer review of laboratory notebooks for accuracy and compliance to microbiological methods.
• Revise standard operating procedures (SOPs) for the microbiology laboratory; revisions may be related to procedural improvements, customer requests and/or audit observations.
• Perform investigations; write problem reports prior to QA review; write and complete deviations and Corrective and Preventative Actions (CAPAs); interact with customers as needed.
• Maintain accurate inventory and tracking records of supplies and equipment; Revise, review, and execute IQ/OQ/PQ protocols on laboratory equipment; Troubleshoot and make minor repairs to laboratory equipment; Ensure good housekeeping and maintain benches, laboratory, and supply rooms in a clean and orderly manner in accordance with cGMP’s, USP and FDA requirements.
• Interact with other departments, including quality assurance and production, to ensure a smooth overall workflow.
• Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards.
• Other duties as assigned by management.
Qualifications:
Required Skills/Abilities:
• Knowledge of current USP standards
• Knowledge of microbiological laboratory techniques
• Experience with microbiological instrumentation
• Ability to learn new laboratory equipment and techniques
• Excellent verbal and written communication skills
• Microbiological reasoning, root cause analysis and problem solving
• Technical writing: write, read, understand, and interpret technical writing and instructions
• MS Office skills; particularly Word and Excel
• Math and calculation skills
• Multitask and coordinate with operations and quality assurance simultaneously
• Work with a wide range of people to solve problems and resolve issues
• Work in a fast-paced environment
• Ability to maintain flexible task schedule and workflow
• Highly detail oriented with good record keeping skills
• Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team
Education/Experience:
• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry
• Minimum of 2 years related experience in quality control cGMP laboratory supporting sterile pharmaceutical manufacturing
Physical Requirements:
• Lift up to 35 lbs.
• Ability to work standing in a laboratory for an 8-hour shift
• Ability to successfully gown and work in ISO 5 environment
Training:
• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
Job Type: Full-time
Pay: $55,000.00 - $60,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance
Schedule:
• 8 hour shift
Education:
• Bachelor's (Required)
Experience:
• QC cGMP lab supporting sterile pharma manufacturing: 2 years (Required)
Work Location: In person Show more details...
via LinkedIn
posted_at: 23 days agoschedule_type: Full-time
Description
Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in... the US and international markets, and have a robust
Description
Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in... the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Our Facilities & Engineering Department located in Monmouth Junction, NJ has an immediate need for an experienced Qualification Engineer.
Summary
The Qualification Engineer supports and assists the Facilities & Engineering department with writing and execution of various qualification protocols for production and critical utilities equipment to meet production requirements including deadlines and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements.
Essential Functions
Primary duties/responsibilities
• Responsible for Qualification Engineering activities, including writing protocols and reports complying with cGMPs, SOPs and FDA requirements
• Responsible for supporting and assisting Engineering qualification function by providing documented evidence all company equipment is qualified and remains in a state of control to deliver processes and products complying to all regulatory and business specifications
• Provides Engineering support and collaborates cross functionally with Operations, Packaging and Manufacturing departments on appropriate qualification, programming and troubleshooting issues
• Responsible for design, writing and executing qualification protocols, tests and reports including, but not limited to: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for production equipment based on user, quality, technical and functional requirements
• Responsible for organizing and maintaining the Engineering File Library.
• Creates and revises SOPs, as needed
• Maintains Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental roll-outs
• Prepares appropriate Change Controls and performs associated tasks in an accurate, timely, effective and compliant manner
Requirements
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
• Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry
• Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
• Hands on experience working with qualification protocols (i.e., IQ, OQ, PQ)
• Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
• Proficiency with Microsoft Office, including Project
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
Physical requirements
Manufacturing based position
Ability to use Personal Protective Equipment (PPE Show more details...
Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in... the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Our Facilities & Engineering Department located in Monmouth Junction, NJ has an immediate need for an experienced Qualification Engineer.
Summary
The Qualification Engineer supports and assists the Facilities & Engineering department with writing and execution of various qualification protocols for production and critical utilities equipment to meet production requirements including deadlines and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) requirements.
Essential Functions
Primary duties/responsibilities
• Responsible for Qualification Engineering activities, including writing protocols and reports complying with cGMPs, SOPs and FDA requirements
• Responsible for supporting and assisting Engineering qualification function by providing documented evidence all company equipment is qualified and remains in a state of control to deliver processes and products complying to all regulatory and business specifications
• Provides Engineering support and collaborates cross functionally with Operations, Packaging and Manufacturing departments on appropriate qualification, programming and troubleshooting issues
• Responsible for design, writing and executing qualification protocols, tests and reports including, but not limited to: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for production equipment based on user, quality, technical and functional requirements
• Responsible for organizing and maintaining the Engineering File Library.
• Creates and revises SOPs, as needed
• Maintains Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental roll-outs
• Prepares appropriate Change Controls and performs associated tasks in an accurate, timely, effective and compliant manner
Requirements
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
• Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry
• Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
• Hands on experience working with qualification protocols (i.e., IQ, OQ, PQ)
• Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
• Proficiency with Microsoft Office, including Project
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
Physical requirements
Manufacturing based position
Ability to use Personal Protective Equipment (PPE Show more details...
via ZipRecruiter
schedule_type: Contractorsalary: 10K–10.5K a monthwork_from_home: 1
Description:
· Senior Validation resource (CSV) with experience in UAT, Library and data listings...
· EDC Validation experience required.
· Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process.
· Experience in UAT, Library and data listings.
· Must have experience with
Description:
· Senior Validation resource (CSV) with experience in UAT, Library and data listings...
· EDC Validation experience required.
· Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process.
· Experience in UAT, Library and data listings.
· Must have experience with HP Client-ALM.
· Review of URS document and understand the functionality.
· Responsible for all the validation deliverables as per. compliance.
· Enable change management at the customer, based on change management recommendations.
· Draft, review and execute the IQ/OQ (Test Protocols) scripts.
Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc Show more details...
· Senior Validation resource (CSV) with experience in UAT, Library and data listings...
· EDC Validation experience required.
· Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process.
· Experience in UAT, Library and data listings.
· Must have experience with HP Client-ALM.
· Review of URS document and understand the functionality.
· Responsible for all the validation deliverables as per. compliance.
· Enable change management at the customer, based on change management recommendations.
· Draft, review and execute the IQ/OQ (Test Protocols) scripts.
Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc Show more details...
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