QA Release

Job Title : QA Release Location: Swiftwater, PA   About the job:  Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.  This role will operate under flexibility to perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met.  This role supports core activities:  Preparation & Certification of Working Documents, Quality Review of Batch Records from Swiftwater and CMOs, Batch Disposition from Swiftwater and CMOs, Quality Review of Lot Release Protocols, Compliance and Performance.           Benefits of working in this role:  • Be part of an inspiring mission to create life-saving vaccines  • Leading a skilled and motivated team of quality professionals  • The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.    Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.   About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives     Main Responsibilities Quality Review of Batch Records  • Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.  • Complete all required system transactions associated with the batch record review process.  • Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.    Disposition of Batches  • Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.  • Verify CBER release is received (if applicable) prior to batch disposition.  • Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.  • Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.  • Complete all required system transactions associated with the batch disposition process.  • Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned    Quality Preparation and Review of Lot Release Protocol (LRP)  • Prepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.  • For licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.  • Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.    Preparation of Environmental Monitoring Summary (ESUM)  • Oversee the ESUM process to ensure timelines and compliance standards are met.  • Take assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database, and meeting release timelines.  • Serve as the SME and function as a liaison for any assigned focus factory initiatives and participate on teams, communicating issues and identifying solutions t