QA Batch Release Lead – Vaccine Manufacturing

Sanofi

Pennsylvania

On-site

USD 69,000 - 100,000

Full time

2 days ago

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Benefits offered by this job

Health and wellness benefits

Parental leave (14 weeks)

Career growth opportunities

Job summary

Sanofi in Swiftwater, PA is seeking a QA Batch Release specialist to ensure product quality through batch release processes for the site. The role supports preparation and certification of working documents, batch record reviews, and disposition decisions to enable timely releases.

You will review LRPs, oversee ESUMs, and ensure compliance with GMP and FDA regulations. Ideal candidates will have a Bachelor’s degree and 1+ years in GMP pharma, with strong attention to detail and proficiency in MS

Qualifications

Bachelor’s degree required.
1+ years of GMP-controlled pharma experience.
Strong attention to detail and documentation accuracy.
Proficient in MS Office and data analysis.

Responsibilities

Quality Review of Batch Records and ensure compliance with regulations (cGMP, FDA).
Disposition of batches after verifying testing requirements and certificates.
Prepare and review Lot Release Protocols (LRP) for health authorities and internal stakeholders.
Prepare ESUM reports and manage timelines for release.
Certify batch records and provide documentation for production planning.