Genzyme Corporation
QA Release Senior Quality Reviewer
Swiftwater, PA · Senior
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About the role
- This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market.
- 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
- Perform final approval of batch release protocol product configurations
- Perform ship approval for batches destined for international countries.
- Participating in internal and external audits and regulatory inspections providing support and documentation
- Perform any other tasks assigned by Manager
- Be part of an inspiring mission to create life-saving vaccines
Requirements
- Bachelor's degree.
- 3+ years of experience in Quality Assurance within the pharmaceutical industry.
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
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)
- 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
- 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.
- Why choose us?
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
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 Genzyme Corporation's careers page and normalized into a canonical job model.