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 to support release timelines.

• Contribute to team objectives and priorities on assigned projects.

Preparation & Certification of Working Documents

• Prepare batch records from master documents in the electronic document management system according to procedure

• Ensure right first-time preparation and completion of required documentation via electronic system (SAP and/or FaCT)

• Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.

• Certified prepared batch records to ensure completeness and accuracy in accordance to procedure.

• Provide metrics in support of +QDCI board meetings.

Compliance and Performance

• Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.

• Investigate deviations, as assigned.

• Perform special projects as assigned by FFIP QA Leadership team.

• Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

• Perform CAPA review and approval as required

• Completion of additional tasks as assigned by Team Lead

Key Involvement in Decision Making:

• Prioritize quality and compliance objectives (D)

• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

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