QA Release

About the Role

As a QA Batch Review Specialist within our Quality Assurance team, you will ensure product quality through batch release processes for the Swiftwater Site. This role operates with flexibility to meet compliance requirements and manufacturing/release schedules, supporting core activities such as batch record review, batch disposition, lot release protocol preparation, and compliance.

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 health authority regulations. Complete system transactions, provide data for PDR manufacturing dates, and Commodity Verification Sheets.
• Disposition of Batches: Review specifications, Certificates of Analysis/Conformance, and verify testing requirements. Ensure CBER release (if applicable) and resolve holds before disposition. Verify all manufacturing steps and raw materials are satisfactory.
• Quality Preparation and Review of Lot Release Protocol (LRP): Prepare and review LRPs for completeness and accuracy. Ensure compliance with GMP and marketing authorization requirements for international products. Meet cycle time requirements and SAP confirmation.
• Preparation of Environmental Monitoring Summary (ESUM): Oversee ESUM process, compile and review data, finalize reports in the electronic database, and meet release timelines. Serve as SME for focus factory initiatives.
• Preparation & Certification of Working Documents: Prepare batch records from master documents, ensure accuracy, and certify completeness. Provide metrics for +QDCI board meetings.
• Compliance and Performance: Meet safety, quality, productivity, and cost targets. Act as trainer, investigate deviations, and perform special projects. Continuously review processes and implement enhancements.

Qualifications

• Bachelor’s degree.
• 1+ years of experience in a GMP-controlled pharmaceutical environment (Quality Assurance, Production, Quality Control, or related areas).

Skills

• Technical Skills: Meticulous review of batch records, issue resolution, multi-project management, and strong computer literacy (Microsoft Excel, PowerPoint, Word).
• Soft Skills: Data analysis, attention to detail, problem-solving, strong communication, and high autonomy.

About Sanofi

We are an R&D-driven, AI-powered biopharma company committed to improving lives through innovative medicines and vaccines. Join us to power life-changing treatments, leverage cutting-edge technology, and transform global healthcare.

Why Choose Us?

• Be part of a mission to create life-saving vaccines.
• Lead and collaborate with skilled quality professionals in a technical vaccine manufacturing environment.
• Join a global network that delivers seamlessly and at scale.
• Enjoy growth opportunities, a well-crafted rewards package, and comprehensive health and wellbeing benefits.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to protected characteristics.