Product Transfer Quality Assurance Lead Job

Zoetis, Inc. documents for accuracy, completeness, and compliance with Outlines of Production, Methods of Manufacture, and provide QA approval. Reviewing and approving validation protocols and reports. Working closely with VMRD, VMRA, GMT and GMS in the preparation and review of Outlines of Production, Methods of Manufacture. Ensuring VMRD Master Seed and Pilot Plant production facilities and the transfer of newly developed and/or improved biological and bio pharmacological products and processes comply with applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of destination countries. Working in conjunction with VMRD CoDev/QA colleagues on scale-up, technical transfers (manufacturing and analytical) and coordination of regulatory issues. Serving as QA consultant for the VMRD Pilot Plant and Master Seed Facility. Supporting VMRD colleagues and initiatives by providing regulatory documents and manufacturing quality/compliance resources. Ensuring continued regulatory compliance within Lincoln operations by actively participating on teams and making appropriate recommendations when needed to assure compliance. Advising Management of quality and/or regulatory deficiencies when products do not meet Zoetis or government requirements; and maintaining a high level of contemporary knowledge in the technical disciplines appropriate to vaccine development and biopharmaceutical manufacture. Bachelor’s degree in Biological Sciences, Pharmaceutical Sciences, Engineering, Biotechnology or related and 10 years of experience including 5 years of experience in quality assurance/control, manufacturing, or regulatory affairs or Master’s degree in Biological Sciences, Pharmaceutical Sciences, Engineering, Biotechnology or related and 8 years of experience including 5 years of experience in quality assurance/control, manufacturing, or regulatory affairs required. Telecommuting may be permitted. When not telecommuting, must report to worksite. To apply, email your resume to [email protected] and reference job #9446221