Zoetis · 4 months ago
Product Development Quality Assurance Senior Associate
Lincoln
Full-time
Onsite
Mid, Senior Level
3+ years expZoetis is a leading global animal health company dedicated to supporting veterinarians and livestock producers. The Product Development Quality Assurance Senior Associate provides quality assurance oversight for biological starting materials and raw materials used in the development of veterinary medicinal products, ensuring compliance with internal and regulatory standards.
AgricultureBiotechnologyHealth CareMedicalPharmaceuticalVeterinary
Responsibilities
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
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
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
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
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
Qualification
Required
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
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
Preferred
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
Company
Zoetis
Zoetis is an animal health company that advances care for animals and supports their health and wellbeing.
10001+ employees
H1B Sponsorship
Zoetis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (136)
2024 (80)
2023 (89)
2022 (126)
2021 (47)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$3.62BKey Investors
Bill & Melinda Gates Foundation
2025-12-16Post Ipo Debt· $1.75B
2025-08-11Post Ipo Debt· $1.85B
2023-03-01Grant· $15.3M
Leadership Team
Kristin Peck
Chief Executive Officer
Chitra Varma
Head, Commercial ERP Products
Recent News
The Motley Fool
2026-01-02
Morningstar.com
2025-12-29
Company data provided by crunchbase