Product Development Quality Assurance Senior Associate

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

Cross-functional Collaboration

Continuous Improvement

Raw Material Support

Basic Qualifications

Preferred Qualifications

Full time

Regular

Colleague

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