Zoetis
Product Development Quality Assurance Senior Associate
Zoetis, Lincoln, Nebraska, United States, 68511
Product Development Quality Assurance Sr. Associate
The Product Development Quality Assurance 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 Quality Systems & Compliance Cross-functional Collaboration Continuous Improvement Raw Material Support Qualifications Bachelors or Masters 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. Strong documentation, organizational, and communication skills. Experience utilizing enterprise systems to support documentation, traceability, and process management activities is highly desirable. Demonstrated ability to work independently and in cross-functional teams. Ability to travel as needed (515%). 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.
The Product Development Quality Assurance 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 Quality Systems & Compliance Cross-functional Collaboration Continuous Improvement Raw Material Support Qualifications Bachelors or Masters 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. Strong documentation, organizational, and communication skills. Experience utilizing enterprise systems to support documentation, traceability, and process management activities is highly desirable. Demonstrated ability to work independently and in cross-functional teams. Ability to travel as needed (515%). 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.