QA Release Specialist - Vaccine Batch Quality

Sanofi; Swiftwater (Monroe County); On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a QA Release specialist to manage batch review and release activities ensuring compliance with cGMP, FDA regulations, and site procedures.

You will perform final quality reviews of batch records, support batch disposition, and prepare Lot Release Protocols, ESUMs, and working documents, while collaborating with a cross-functional QA team to meet release timelines.

Qualifications

• Bachelor's degree and 1+ years in GMP pharmaceutical environment.
• Meticulous batch record review and documentation.
• Strong attention to quality, compliance, and regulatory standards.

Responsibilities

• Quality review of batch records for completeness and accuracy.
• Disposition of batches after verification of testing results.
• Prepare and review Lot Release Protocols (LRP) for regulatory submission.
• Prepare ESUM summaries and ensure release timelines are met.
• Prepare and certify working documents and provide QA metrics.

Skills

Batch record review

GMP experience

Data analysis

Quality Assurance

Microsoft Excel

Communication skills

Education

Bachelor's degree

Tools

SAP

FaCT

Job description

Sanofi in Swiftwater, PA is seeking a QA Release specialist to manage batch review and release activities ensuring compliance with cGMP, FDA regulations, and site procedures.

You will perform final quality reviews of batch records, support batch disposition, and prepare Lot Release Protocols, ESUMs, and working documents, while collaborating with a cross-functional QA team to meet release timelines.