Quality Control Analyst jobs at Johnson & Johnson - 408 jobs

Quality Control Supervisor Our client, a leading biopharmaceutical company, is seeking an experienced Quality Control Supervisor to join their team. This role is responsible for overseeing QC operations in a GMP-regulated environment, ensuring compliance with regulatory standards and internal procedures. Key Responsibilities: Supervise and mentor QC analysts; provide technical guidance and support. Ensure compliance with cGMP, USP, and 21 CFR Parts 210 & 211. Review and approve analytical data, investigations, and CAPAs. Troubleshoot analytical instruments (HPLC, GC, PSD) and support method validation and transfers. Manage testing schedules for raw materials, finished products, stability, and validation samples. Qualifications: BS in a scientific discipline with 5+ years of experience or MS with 3+ years. Hands-on experience with HPLC and Empower software. Strong knowledge of cGMP, USP, and ICH guidelines. Supervisory experience required. This is an excellent opportunity to join a growing organization and make an impact, please apply in directly for more information!

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. **Schedule:** Sunday - Wednesday 6:00AM - 4:30PM **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. + Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed + Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss + Initiate the production of batch documentation used for engineering and cGMP production. + Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes + Complete executed Batch Records accurately and completely prior to submission to supervision for review + Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements + Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions + Cross train to increase technical skills across the department + Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. + As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. + Work with enabling groups to improve/implement processes. + Other duties as assigned. + Strong interpersonal skills + Strong working knowledge of MS Office suite is preferable + Attention to detail and positive attitude are key attributes + Able to follow rules and regulations perfectly + Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Required:** + High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred + Experience and knowledge of formulation/compounding tools and equipment + Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations + Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. \#LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **QC Scientist I Raw Materials** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. **Essential Job Responsibilities:** + Develop/author/revise technical reports and laboratory procedures (SOPs, methods) + Execute and troubleshoot raw material testing in support of production activities + Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures + Design and perform testing in support of method transfer/validation/qualification/verification + Review/authorize data and perform analysis and interpretation of test results and trends + Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations + Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration + Support and mentor junior team members + Collaborate with other network sites to share best practices + Other duties as required **Quantitative Dimensions:** The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. **Organizational Context:** The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Indianapolis, IN, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. **Job Description** + Perform evaluations and laboratory testing on primary container-closure components and system, critical secondary packaging, and shipping systems utilizing mechanical testing equipment, dimension measurement instruments, and container closure integrity testing systems + Execute methods, collect data, and document results in lab notebooks and LIMS + Participate in the development of laboratory test methods or equipment to ensure reliability and accuracy of results + Interact with colleagues in other groups on a routine basis + Ensure all activities follow established safety standards, regulatory requirements and Good Manufacturing Procedures (GMP) **Qualifications** + Bachelor's in science, engineering, or technology, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) + At least 4-10 years of related laboratory experience **Additional Information** + Position is full-time, Monday-Friday, 8:00 am - 5:00 pm. + Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply + Excellent full-time benefits including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays + **\#LI-EB1** + Authorization to work in the United States indefinitely without restriction or sponsorship **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**

1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. 2. Maintain detailed and comprehensive documentation of all work performed. 3. Stay current with the scientific literature, particularly in areas that may affect companys product line, existing processes or potential commercial opportunities. 4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. 5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. 6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. 7. Provide support to QA/QC by writing analytical SOPs. 8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. 9. Provide monthly report on progress of work to the department head. 10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. 11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. 12. Work closely with Synthesis group and support on routine analysis. 13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. 14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. 15. Work closely with R&D team to answer DMF deficiencies and customer queries. 16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). 17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. 18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. 19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. 20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. 21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. 22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. 23. Seek out opportunities for professional development. 24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. 25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. 26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. 27. Other duties as assigned. **Position Requirements:** + B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. + Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. + Ability to communicate effectively through verbal, written, presentation and computer modes of expression. + Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). _The presently-anticipated base compensation pay range for this position is $102,500 to $125,000. 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, and may be eligible for the Long Term Incentive 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._ 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.

* Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. * Maintain detailed and comprehensive documentation of all work performed. * Stay current with the scientific literature, particularly in areas that may affect company's product line, existing processes or potential commercial opportunities. * Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. * Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. * Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. * Provide support to QA/QC by writing analytical SOPs. * Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. * Provide monthly report on progress of work to the department head. * Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. * Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. * Work closely with Synthesis group and support on routine analysis. * Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. * Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. * Work closely with R&D team to answer DMF deficiencies and customer queries. * Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). * Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. * Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. * Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. * Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. * Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. * Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. * Seek out opportunities for professional development. * Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. * Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. * Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. * Other duties as assigned. Position Requirements: * B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. * Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. * Ability to communicate effectively through verbal, written, presentation and computer modes of expression. * Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). The presently-anticipated base compensation pay range for this position is $102,500 to $125,000. 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, and may be eligible for the Long Term Incentive 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. Nearest Major Market: Chattanooga

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.

Job Description The Laboratory Technician is responsible for performing routine and advanced analytical and microbiological testing to support the manufacture, release, and ongoing quality of sterile drug products produced in a 503B outsourcing facility. The Technician executes compendial methods following United States Pharmacopeia (USP) requirements, including but not limited to USP Sterility Tests, USP Microbial Enumeration, USP pH, USP Osmolality, USP Particulate Matter, and USP Visible Particulates. Additional responsibilities include organism identification, environmental monitoring support, data analysis, equipment usage, and strict adherence to all Standard Operating Procedures (SOPs), and GxP regulations.The role requires exceptional attention to detail, technical proficiency, strong documentation practices, and the ability to work efficiently in a fast-paced and highly regulated sterile manufacturing environment. Responsibilities: Analytical and Microbiological Testing • Perform compendial testing on raw materials, in-process samples, and finished drug products, including but not limited to USP , , , , , and . • Conduct microorganism identification using phenotypic platforms (e.g., MALDI-TOF) • Perform growth promotion tests, media qualifications, and sterility qualifications as required. • Execute method suitability and method verification activities according to SOPs and regulatory guidance. • Support environmental monitoring (EM) investigations by analyzing isolates and trends. • Prepare media, reagents, dilutions, and controls as needed for routine testing. • Other duties as assigned. Data Review, Documentation & Compliance • Record all testing activities in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). • Analyze and interpret data, ensuring results meet specifications and cGMP expectations. • Report atypical, out-of-specification (OOS), and out-of-trend (OOT) results promptly. • Follow all SOPs, test methods, and work instructions without deviation unless approved through the change control process. • Maintain accurate instrument logs, calibration records, and laboratory notebooks. • Support quality audits and regulatory inspections as needed. Equipment Operation & Maintenance • Operate laboratory instruments such as micro-osmometers (e.g., OsmoTECH Pro), pH meters, microscopes, particle counters, TOC meters (if applicable), and microbiology identification systems. • Perform routine instrument calibrations, verifications, and daily system suitability checks. • Document equipment usage and maintenance activities. • Troubleshoot basic issues and escalate instrumentation problems to supervisors, quality, or engineering. Quality, Safety & Continuous Improvement • Maintain a clean, organized, and compliant laboratory workspace, including adherence to aseptic techniques and contamination control practices. • Comply with all laboratory safety policies, including proper PPE use and handling of hazardous materials. • Participate in continuous improvement initiatives, CAPAs, and cross-functional projects. Required Skills/Abilities: • Excellent verbal and written communication skills. • Attention to Detail: Ensures accuracy in testing, data entry, and documentation. • Technical Proficiency: Able to execute complex laboratory methods with minimal supervision. • Problem Solving: Identifies issues promptly and contributes to laboratory investigations. • Communication: Clearly documents findings and communicates issues to management. • Teamwork: Collaborates effectively in a cross-functional environment. • Compliance Mindset: Demonstrates strong cGMP ethics and commitment to data integrity and impartiality. Education and Experience: • Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline. • 1-3 years of laboratory experience in a regulated environment (503B, 503A, CGMP, Pharmaceutical QC, GLP, or similar). • Working knowledge of USP compendial methods for sterile products. • Strong understanding of aseptic technique and contamination control. • Proficiency in Microsoft Office, LIMS/ELN platforms, and data entry. Physical Requirements: • Ability to stand for extended periods while performing laboratory procedures. • Ability to lift up to 25 lbs. (media, solvent containers, equipment parts). • Work performed in controlled cleanroom and laboratory environments. • Position may require occasional weekend, holiday, or off-shift work depending on production needs

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations With guidance, participates in OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training Maintains assigned training records current and in-compliance May assist in the training of less senior laboratory staff 5% Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: * Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. * Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. * Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. * Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. * Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. * Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: * Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. * Ensure that expired chemicals and reference standards are removed from laboratory area. * Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. * Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Schedule: Tuesday to Friday 3 PM Until 1:30 AM (or until work is completed) Pay: $25/hour SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.

Role Description Lab Tech 1 - Chemistry SHIFT: Monday-Friday 10:00 pm - 6:30 am The Lab Technician 1 is responsible for performing routine laboratory tests to support the diagnosis and treatment of animal health conditions. Key responsibilities include preparing samples, operating laboratory equipment, and maintaining accurate records. This role supports the Global Diagnostics division at Zoetis and will work closely with internal veterinarians or medical team, and other lab personnel to ensure the highest standards of quality and accuracy in our diagnostic services. Job Duties: * Prepare biological specimens for testing in various departments, including but not limited to, hematology, urinalysis, serology, chemistry, endocrinology, parasitology, cytology, and coagulation * Use high-throughput automated analyzers, microscopes, and other diagnostic equipment to test various sample types, including but not limited to, whole blood, serum, urine, and feces * Set up and execute laboratory tests, review results, and release findings in accordance with ZRL Standard Operating Procedures (SOPs) * Perform routine and non-routine maintenance on analyzers, including but not limited to, daily, weekly, monthly, and as needed maintenance * Perform basic analyzer troubleshooting techniques on one major department analyzer * Review and accept daily Quality Control reports and weekly Levey-Jennings charts * Handle and store all biological specimens in accordance with ZRL Standard Operating Procedures (SOP) * Maintain a clean and organized laboratory workspace * Properly handle and dispose of medical and biohazardous waste while adhering to all applicable regulatory guidelines * Consistently and properly fill out laboratory logs, including but not limited to maintenance logs, environmental logs, and cleaning logs * Maintain several types of records, including but not limited to medical records, courier logs and manifests * Prepare biological specimens for shipment to offsite testing facilities, adhering to all standards set forth by regulatory bodies including the Department of Transportation (DOT) * Receive, store, and log all laboratory and office supplies into designated locations * Operate and maintain secondary laboratory equipment, including but not limited to centrifuges, pipettes, heating blocks, and slide stainers * Understand and follow SOPs and training modules set forth by Zoetis Reference Laboratories Education/Experience: * High School Diploma or equivalent required. * Associate or Bachelor's degree preferred. * Requires 1-2 years of experience in a clinical laboratory setting and experience in performing basic laboratory testing or operations * Proficient knowledge in one of the following preferred: Hematology, Chemistry, Urinalysis, Endocrinology, Parasitology, and Cytology Technical Skills Required: * Strong attention to detail * Proficiency in using laboratory equipment and software. * IT and LIS (laboratory information systems) experience and general comfort level with computer systems, technology, and equipment interfaces. * Team-oriented with excellent collaboration skills * Ability to work independently and as part of a team * Robust organizational and time management abilities * Excellent data entry skills * Strong written and oral communication skills * Ability to complete tasks with minimal supervision * Fluency in English language Physical Position Requirements: * Ability to lift up to 50 pounds * Ability to bend, kneel, stoop, crouch * Ability to walk, sit, or stand for extended periods Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Role Description Lab Tech 1 - Chemistry SHIFT: Monday-Friday 10:00 pm - 6:30 am The Lab Technician 1 is responsible for performing routine laboratory tests to support the diagnosis and treatment of animal health conditions. Key responsibilities include preparing samples, operating laboratory equipment, and maintaining accurate records. This role supports the Global Diagnostics division at Zoetis and will work closely with internal veterinarians or medical team, and other lab personnel to ensure the highest standards of quality and accuracy in our diagnostic services. Job Duties: · Prepare biological specimens for testing in various departments, including but not limited to, hematology, urinalysis, serology, chemistry, endocrinology, parasitology, cytology, and coagulation · Use high-throughput automated analyzers, microscopes, and other diagnostic equipment to test various sample types, including but not limited to, whole blood, serum, urine, and feces · Set up and execute laboratory tests, review results, and release findings in accordance with ZRL Standard Operating Procedures (SOPs) · Perform routine and non-routine maintenance on analyzers, including but not limited to, daily, weekly, monthly, and as needed maintenance · Perform basic analyzer troubleshooting techniques on one major department analyzer · Review and accept daily Quality Control reports and weekly Levey-Jennings charts · Handle and store all biological specimens in accordance with ZRL Standard Operating Procedures (SOP) · Maintain a clean and organized laboratory workspace · Properly handle and dispose of medical and biohazardous waste while adhering to all applicable regulatory guidelines · Consistently and properly fill out laboratory logs, including but not limited to maintenance logs, environmental logs, and cleaning logs · Maintain several types of records, including but not limited to medical records, courier logs and manifests · Prepare biological specimens for shipment to offsite testing facilities, adhering to all standards set forth by regulatory bodies including the Department of Transportation (DOT) · Receive, store, and log all laboratory and office supplies into designated locations · Operate and maintain secondary laboratory equipment, including but not limited to centrifuges, pipettes, heating blocks, and slide stainers · Understand and follow SOPs and training modules set forth by Zoetis Reference Laboratories Education/Experience: · High School Diploma or equivalent required. · Associate or Bachelor's degree preferred. · Requires 1-2 years of experience in a clinical laboratory setting and experience in performing basic laboratory testing or operations · Proficient knowledge in one of the following preferred: Hematology, Chemistry, Urinalysis, Endocrinology, Parasitology, and Cytology Technical Skills Required: · Strong attention to detail · Proficiency in using laboratory equipment and software. · IT and LIS (laboratory information systems) experience and general comfort level with computer systems, technology, and equipment interfaces. · Team-oriented with excellent collaboration skills · Ability to work independently and as part of a team · Robust organizational and time management abilities · Excellent data entry skills · Strong written and oral communication skills · Ability to complete tasks with minimal supervision · Fluency in English language Physical Position Requirements: · Ability to lift up to 50 pounds · Ability to bend, kneel, stoop, crouch · Ability to walk, sit, or stand for extended periods Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Qualifications Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and CGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data. Responsibilities Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Strong chemistry knowledge with proven ability to handle various project loads is beneficial. Education, Experience & Licensing Requirements Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.