Senior Associate Scientist - Lincoln
23 hours ago
Job description
The Product Development QA Sr. Associate provides quality assurance oversight for biological starting materials (Master Seed/Cell Banks) and raw materials for immunological and biopharmaceutical products used in the research and development of veterinary medicinal products. The role is compliance focused and is responsible for reviewing and approving documents related to raw material selection, production, and testing. Additional responsibilities include generating certificates of analysis and TSE/BSE compliance statements for both internal and external use. The Sr. Associate partners closely across R&D, Master Seed/Master Cell (MS/MC) Manufacturing, Supply Chain, and Regulatory Affairs teams, and is responsible for ensuring compliance with internal quality standards and regulatory guidelines, including those from the USDA Center for Veterinary Biologics (CVB), FDA Center for Veterinary Medicine (CVM), and EMA Committee for Medicinal Products for Veterinary Use (CVMP).
Key Responsibilities
Master Seed/Cell Bank Quality Oversight
• Oversee the establishment, characterization, and maintenance of MS/MC banks in compliance with internal and regulatory standards.
• Review and approve production records, testing records, stability reports, and requalification documentation to ensure accuracy, completeness, and compliance with regulatory and internal requirements.
• Ensure traceability and documentation of all Master Seed/Cell banks.
Quality Systems & Compliance
- Review and approve SOPs, protocols, risk assessments and other process documents related to biological bank activities and material selection.
- Partner closely with Global and Site-based Manufacturing Quality Assurance to align with on-site operational requirements and best practices.
- Conduct internal compliance audits of MS/MC processes, ensuring alignment with internal procedures, quality standards and regulatory requirements.
- Investigate deviations, non-conformances, and implement effective CAPA associated with master seed / cell production and raw material selection.
- Support internal, external, and regulatory inspections acting as subject matter expert for MS/MC banks and associated raw materials.
- Utilize Global Quality Systems, as needed, including SAP, ETS and Veeva Vault.
Cross-functional Collaboration
- Work with R&D, MS/MC Manufacturing, Regulatory Affairs, and Supply Chain to ensure compliance during development and production of MS/MC banks.
- Provide QA guidance during development and scale-up of new MS/MC banks and processes.
- Participate in staff and project meetings, document reviews, and consultations with VMRD colleagues.
Continuous Improvement
- Identify and support improvements in QA processes, documentation practices, and material selection.
- Monitor regulatory trends and update practices to maintain compliance.
- May assume a lead role for various QA projects within the PSQL group and/or VMRD.
Raw Material Support
- Support the identification, selection, and risk evaluation of raw materials and critical reagents used during research and development.
- Assist in developing specifications, risk assessments, and control strategies for raw materials, ensuring alignment with relevant regulatory expectations.
- Support review of supplier documentation, certificates of analysis, and change notifications.
Basic Qualifications
• Bachelor's or Master's degree in Biology, Microbiology, Biotechnology, Chemistry, Animal Science, or related field.
• 3+ experience in Quality Assurance within the pharmaceutical, biotechnology, or animal health industry with
• Experience with product development, biological bank oversight, and/or raw material selection.
• Working knowledge of GMP, GLP, and relevant regulatory requirements (e.g., USDA, FDA, EMA).
• Experience utilizing enterprise systems (e.g., SAP, ETS, Veeva Vault) to support documentation, traceability, and process management activities is highly desirable.
Preferred Qualifications
• Experience with veterinary biologics or vaccines.
• Familiarity with cell culture, fermentation, or seed / cell bank processes.
• Experience leading QA projects or compliance initiatives.
• Demonstrated ability to work independently and in cross-functional teams.
• Ability to travel as needed (5–15%).
• Experience supporting regulatory submissions, inspections, or compliance activities is highly desirable.
• Strong documentation, organizational, and communication skills.
• Demonstrated proficiency for documentation review with a strong attention to detail.
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 "". 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.Similar jobs
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