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

Skills

Key technologies and capabilities for this role

Quality AssuranceCompliance OversightSOP ReviewProtocol ApprovalRisk AssessmentInternal AuditsDeviation InvestigationCertificates of AnalysisTSE/BSE ComplianceMaster Seed BanksMaster Cell BanksRegulatory ComplianceUSDA CVBFDA CVMEMA CVMP

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

What is the work location or remote policy for this role?

This information is not specified in the job description.

What key skills and experiences are required for this position?

The role requires expertise in quality assurance oversight for biological starting materials, compliance with USDA CVB, FDA CVM, and EMA CVMP regulations, reviewing/approving production records and SOPs, conducting audits, investigating deviations/CAPAs, and proficiency with systems like SAP, ETS, and Veeva Vault.

What is the team structure or collaboration like in this role?

The role involves partnering closely with R&D, Master Seed/Master Cell Manufacturing, Supply Chain, Regulatory Affairs, Global and Site-based Manufacturing Quality Assurance, and VMRD colleagues, including participation in staff and project meetings.

What makes a strong candidate for this QA Senior Associate role?

Strong candidates will have deep compliance expertise in biological materials for veterinary products, experience with regulatory audits/inspections, cross-functional collaboration skills, and the ability to drive continuous improvements and CAPAs.