Quality Control Analyst jobs at Sanofi US

This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products. Responsibilities: Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements. Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations. Document all laboratory testing and maintain accurate and legible notebooks and records. Peer review of data, reports and notebooks. Other projects and duties as assigned. Experience/Education Requirements: BS Degree in Chemistry or related field AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment Knowledge of cGMP, USP/NF, and FDA guidelines and regulations Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations) Excellent oral and written communication skills Strong organization and time management skills Demonstrated ability to work as part of a cross-functional team Working knowledge of Microsoft Word and Excel Experience with software associated with a Laboratory Information Management System (LIMS) Work mainly performed in lab Stand for extended periods of time in a laboratory setting Wear Personal Protective Equipment (PPE) as needed Work with hazardous chemicals as needed to complete laboratory testing

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

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.

TITLE: QC Analytical Scientist Title: QC Analytical Scientist Reports To: QC Analytical Manager Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category. POSITION SUMMARY: We are seeking a QC Analytical Scientist responsible for a unique opportunity to facilitate the startup of the GMP testing laboratory. Candidates will conduct method transfers, method verifications/validations as per USP and ICH guidelines. Some method development may be needed. This role will report to the QC Analytical Manager and candidates will work in a collaborative team setting. This role is responsible for supporting and assisting with the delivery of the project timeline and critical milestones. This role will also work in a manner that assures quality, safety, efficacy, and compliance to regulatory requirements. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Support the start-up the QC Laboratory and transition to routine analytical testing. Support technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and any additional studies related to Manufacturing. Perform and review instrument qualifications and manage calibrations. Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory. Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes. Independently write and implement study protocols and reports. Keep accurate documentation as per current Good Manufacturing Practices (cGMP). Experience performing QC analyses with different instruments (wet chemistry, HPLC, GC, KF, FTIR, UV-VIS) required. Perform analyses and peer reviews. Identify and document deviations and conduct laboratory investigations. MINIMUM QUALIFICATIONS: Bachelor's Degree in a Scientific field with minimum 3-5 years of experience in the pharmaceutical industry Experience with method validation/verification/transfers required. Experience performing instrument and software qualifications is preferred. Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred. Experience in relevant laboratory, computer, and data analysis skills. NMR experience is preferred but not required. Strong organizational abilities, problem-solving skills, resourceful, and accountable. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept. Ability to handle a wide variety of tasks under critical time constraints. Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and critical thinking. Ability to work varied schedule with some potential weekend, early morning, or late evening hours, if needed (seldom needed). BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Always act with honesty and integrity. Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Always act with honesty and integrity Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled

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). 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.

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.

Eurofins Scientific is a network of independent companies 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 to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients-including DoD, DOE, and municipalities-through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description Eurofins Environment Testing is seeking a Laboratory Analyst to join our team! The Laboratory Analyst will have previous experience or exposure to GC/MS Volatiles testing. The Laboratory Analyst prepares and analyzes environmental samples using standard analytical techniques according to scientific and EPA methodology in compliance with Eurofins' Quality Assurance programs and SOP's. Position Summary: responsibilities include, but are not limited to, the following: * Routine sample preparation and analysis of air samples * Perform all documentation, sample preparation and analysis, following SOPs or appropriate methods * Demonstrated ability to work in a fast-paced and productive environment * Strong organization with the ability to follow instructions and SOP * Proactively communicate production and quality issues to management * Accuracy and attention to detail * Prepare standards * Effective communication skills, both written and oral * Demonstrate and promotes the company vision * Understand and use Air Toxics LIMS system * Perform other duties as assigned * Participate in laboratory and other meetings * Perform other duties as required by Company management Qualifications * Bachelor's degree in a science related field is required * Experience working in a fast paced environment * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Skills and Abilities * Strong sense of initiative, detail oriented with a hands-on approach * Ability to work efficiently and accurately within a fast paced environment * Effective communication skills, both written and verbal * Strong team working skills and the ability to conduct all activities in a safe and efficient manner * Regular attendance and punctuality * Ability to learn new techniques, adapt setup and test equipment to new situations, perform multiple tasks simultaneously, and keep accurate records; * Method development experience * Proficiency with data processing software and Microsoft programs. * Able to perform the physical requirements of the job * Demonstrates and promotes the company vision * Able to work a full-time shift (M-F) during training; flexible to rotate weekends and overtime as necessary * Adherence to safety protocol and operation procedures; * Excellent customer service; resourceful and collaborative approach in solving problems; function in an environment of constant change and conflicting priorities; * Communicate well with coworkers and management; * Read, understand and comply with SOPs; * Concentrate, focus, and be attentive to details; * Use a keyboard to enter data; * Work under medium to high stress level; * Ability to lift up to 25 pounds on a continuous basis, stand for prolonged periods; work upright, bend and use hands and arms repetitively to perform moderate physical work duties; the ability to push carts with objects on board weighing up to 50 pounds; hearing and speaking are needed to listen effectively and talk with individuals in person or on the phone; specific vision abilities required by this job include; close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus. Hazardous Material Handling: The Eurofins Air Toxics laboratory houses chemicals necessary for the analysis of various environmental samples. These chemicals can be harmful if not properly handled. The list includes but is not limited to; cryogenic Dewars of liquid nitrogen, compressed gasses including helium, nitrogen and hydrogen, sharps and liquid solvents such as methylene chloride, acetonitrile and acetone. This position requires the ability to safely handle and transport these bulk chemicals. The employee will be required to read and reference the Chemical Hygiene Plan and Injury and Illness Prevention Program for additional information and instruction. Additional Information Compensation Range: $21 - $23 per hour depending on level of experience and qualifications. Position is full-time, and eligible for overtime pay. Candidates must be available to work the following shift: * Monday - Friday, 2:30pm to 11:00pm and possible overtime and weekends as needed * Initial Training will be Monday - Friday, 8am - 4:30pm Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Company description: 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 discovery pharmacology, forensics, advanced material sciences and agroscience contract research 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 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 2024, Eurofins generated total revenues of EUR 6.151 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Boehringer Ingelheim Animal Health is currently seeking an innovative, tech savvy Co-Op to join our Commercial Quality team located at our Duluth, GA US headquarters. As a Co-Op, you will learn basic quality principles while performing critical process evaluations. The mission of this internship will be to streamline a critical quality process which contributes to the continuity of the US Animal Health Commercial Supply Chain. As a Co-Op at Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Assist Subject Matter Experts in core quality tasks associated with release of batches to the US market, deviation management, and complaint management Evaluate a core quality process and use BI digital tools (i.e. Tableau, Power BI, Dashboards, Excel, DocuSign) to streamline the process Develop and execute quality culture initiatives to spread Quality Culture across the US AH Commercial business Requirements Must be a current undergraduate, graduate or advanced degree student in good academic standing. Student must be enrolled at an accredited college or university for the duration of the Co-Op. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. Major or minor in related field of the Co-Op. Undergraduate students must have completed at least 12 credit hours at current college or university. Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. Desired Skills, Experience and Abilities Advanced skills in Excel, Dashboards, and/or Power BI Strong organization skills Proficient in MS PowerPoint Excellent written and verbal communication Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

The Quality Control Operator ensures the products meet their respective specifications and quality standards by performing physicochemical analyzes, measurement testing, and monitoring steps of the production process. Responsibilities: Product sampling and quality monitoring. Physicochemical analysis of food products. Measurement testing, such as finished product weight and oxygen level. Critical Control Point (CCP) monitoring. Maintenance of quality control records. Compliance with the QA laboratory procedures. Compliance with Good Manufacturing Practices (GMP), and Quality & Food Safety guidelines. Support the 5S program in the manufacturing facility, keeping working areas, utensils, and equipment clean and organized. Compliance with company safety rules and procedures, providing support to eliminate any unsafe conditions. Support to all quality shifts, as needed. Any other duties assigned by the management. Education/Experience/Knowledge: High School Graduate or equivalent work experience. Basic computer skills including Microsoft Office applications and Windows environment. Ability to do math computation and calculation. Ability to maintain a positive work atmosphere by behaving and communicating professionally and effectively with others as well as being able to receive feedback from others. Time management and teamwork skills. Verbal and written communication skills. High level of integrity. Able to work on the weekends, as needed. Bilingual (English and Spanish), preferred. Why work for Advance Services, Inc. 1. Advance Services is for and about people; we are your employment specialists. 2. Enjoy our easy application process. 3. You NEVER pay a fee! 4. Weekly pay. 5. Fun Safety and attendance incentives. 6. Health Benefits to keep you and your family healthy. 7. PTO so you have time for yourself. 8. Great Referral Incentives. 9. Advance Services partners with the top companies in the area! Apply for this job by clicking the apply button. You will be directed to our website. Please select a branch near you or call/text our office at *************. Stop in and see our experienced, friendly staff at 1908 Central Dr, Suite A, Bedford, TX 76021. Advance Services is an equal-opportunity employer.#456

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. * Support microbial testing for commercial and pre-commercial products * Support method development, validation, and transfer activities * Perform complex microbial analyses using lab equipment * Investigate complex product issues and support product development * Manage method lifecycle activities * Write and review SOPs, test methods, and validation documents * Serve as a subject matter expert (SME) in microbial testing * Mentor Scientists and Microbiologists Key Responsibilities * Perform routine microbiological testing on raw materials, in-process samples, and finished products * Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests * Analyze environmental monitoring samples from cleanrooms and production areas * Support Validation of microbial methods for product and raw material testing * Prepare protocols, reports, and test methods * Conduct testing to support development and stability studies * Present and review data with project teams * Review lab documentation and supplier technical documents * Use lab software and detect abnormalities during testing * Provide general lab support and maintain equipment * Troubleshoot instruments and perform follow-up analyses * Report and investigate out-of-specification results * Write and review SOPs and investigation reports that support root cause analysis * Recommend corrective and preventive actions (CAPA) * Support training of microbiologists and improve training process records * Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) * Ensure compliance with FDA and other regulatory standards * Follow safety procedures and handle hazardous materials properly * Uses laboratory software for analyses * Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping * Troubleshoots instrumentation and performs subsequent analyses 20% Investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action * Participates in root cause identification of complex laboratory investigations * Writes, edits, and reviews SOPs and laboratory investigations 10% Training * Trains microbiologists * Continuously updates knowledge with respect to the latest technologies related to Microbiology * Maintains assigned training records current and in-compliance * Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance * Identifies need for SOPs and writes or revises, as appropriate * Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations * Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs * Takes active role in auditing laboratory logbooks/documentation to ensure compliance * 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 Microbiology or related field with 6 years' relevant microbiological laboratory experience OR * Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR * PhD in above disciplines with some relevant 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. * Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. * Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. * Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS * Has demonstrated competence in conducting microbial testing * Strong knowledge of aseptic technique and contamination control * 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 critically review and analyze data, interpret information, and draw conclusions from relevant or missing information * Ability to display and analyze data in a logical manner * Strong verbal and written communication skills as well as good computer skills * Strong attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities * 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 firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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.

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. The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques Has ownership for the daily formulation activities to ensure 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 of errors that could lead to product and or finical loss Troubleshoots and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols. Completes Batch Records accurately and completely prior to submission to supervision for review Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Initiate and support revisions to SOPs and FORMs as needed Participates in investigations, and contribute to identifying corrective and preventative actions Cross trains 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 Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Work with enabling groups to improve/implement processes Other duties as assigned Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Able to stand for long periods of time, the majority of the work shift Able to lift 30lbs repeatedly Able to wear PPE (mask, gloves, respiratory) Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. TRAVEL - < 10% 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. High School education, AS degree or BS degree in related field of study is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Strong communication skills Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Resilient as well as flexible 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.

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.

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: Monday to Thursday 5 AM until 3:30 PM (or until work is completed) Pay: $23/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.

Medical Laboratory Technician to work in the Chemistry/Core Laboratory under the direct supervision of supervisor. Will be responsible for performing a variety of complex and routine test within the Core Laboratory complying with all safety and regulatory requirement. Rotate weekends and scheduled holidays base on the needs of the department; participate in interdepartmental collaboration within the institution, to provide the highest quality patient care.

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 * Run routine assays on instruments including UPLC, LC/MS and NMR * Develop or adapt pre-existing methods based on changing needs and new raw materials * Data analysis outside of lab Qualifications * Bachelors degree in a scientific concentration * Authorization to work in the United States indefinitely without restriction or sponsorship. * Experience with UPLC, LC/MS * Experience with Waters LC systems is a plus, especially UPLC with QDA/PDA * Analytical knowledge, especially working with calibration curves * Knowledge of ICH guidance for validation of analytical procedures * Knowledge of chemistry, especially molecules such as amino acids, sugars, and metals * Experience with Empower software is a plus Additional Information This position is Full-Time, Monday through Friday, 9a.m. to 5 p.m with overtime as needed. Candidates currently living within a commutable distance of Malvern, PA 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 Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.