Sanofi Pasteur Inc.
QA Release
Swiftwater, PA · Junior
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About the role
- 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.
- 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.
Responsibilities
- Be part of an inspiring mission to create life-saving vaccines
Requirements
- Bachelor's degree.
- 1+ years of experience in a GMP-controlled pharmaceutical environment (e.g., Quality Assurance, Production, Quality Control or related areas).
- Complete all required system transactions associated with the batch record review process.
- 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.
- Complete all required system transactions associated with the batch disposition process.
- 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.
- Perform CAPA review and approval as required
Skills
- Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
- Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
- Strong Computer Literacy (including Microsoft excel, power point, word)
- Soft Skills:
- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities
- Proficiency in identifying problems and implementing effective corrective actions
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- High level of autonomy
- Why choose us?
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
Compensation
- All compensation will be determined commensurate with demonstrated experience.
Benefits
- Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
This listing is sourced directly from Sanofi Pasteur Inc.'s careers page and normalized into a canonical job model.