Product Development Quality Assurance Senior Associate at Zoetis

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Veterinary Medicine, Biopharmaceuticals, Animal HealthIndustries

Requirements

Bachelor’s or Master’s degree in Biology, Microbiology, Biotechnology, Chemistry, Animal Science, or related field
Minimum 3-5 years’ experience in Quality Assurance within the pharmaceutical, biotechnology, or animal health industry
Demonstrated proficiency for documentation review with a strong attention to detail
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 supporting regulatory submissions, inspections, or audits

Responsibilities

Oversee the establishment, characterization, and maintenance of Master Seed/Cell (MS/MC) banks in compliance with internal and regulatory standards
Review and approve production records, testing records, stability reports, and requalification documentation for MS/MC banks
Ensure traceability and documentation of all Master Seed/Cell banks
Review and approve SOPs, protocols, risk assessments, and other process documents related to biological bank activities and material selection
Partner with Global and Site-based Manufacturing Quality Assurance to align with operational requirements and best practices
Conduct internal compliance audits of MS/MC processes
Investigate deviations, non-conformances, and implement CAPA for master seed/cell production and raw material selection
Support internal, external, and regulatory inspections as subject matter expert for MS/MC banks and raw materials
Utilize Global Quality Systems (e.g., SAP, ETS, Veeva Vault)
Collaborate with R&D, MS/MC Manufacturing, Regulatory Affairs, and Supply Chain for compliance during development and production
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
Identify and support improvements in QA processes, documentation, and material selection
Monitor regulatory trends and update practices for compliance
Lead QA projects within the PSQL group and/or VMRD
Support identification, selection, and risk evaluation of raw materials and critical reagents
Assist in developing specifications, risk assessments, and control strategies for raw materials
Review supplier documentation, certificates of analysis, and change notifications
Generate certificates of analysis and TSE/BSE compliance statements for internal and external use