Senior QA Release & Batch Compliance Reviewer

Sanofi Group; Swiftwater (Monroe County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Be part of an inspiring mission to be

Lead a skilled quality team

Collaborative vaccine manufacturing on

Job summary

Sanofi in Swiftwater, PA seeks a QA Release Senior Quality Reviewer to provide quality oversight of the Batch Release Protocol process and final release to market. You will review and approve batch release protocols for foreign and domestic submissions, ensuring GMP compliance.

You will collaborate with regulatory affairs, supply chain, and audits, driving continuous quality improvements and supporting regulatory inspections to uphold product quality and patient safety.

Qualifications

• 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

Responsibilities

• Ensure activities are conducted in compliance with regulatory requirements.
• Review and approve batch release protocols.
• Coordinate with supply chain and regulatory affairs to schedule batch release protocols and priorities.
• Perform ship approval for batches destined for international countries.
• Support internal and external audits and regulatory inspections with documentation.
• Investigate and resolve issues or deviations related to batch release (incl. temperature excursions).
• Collaborate with regulatory affairs to ensure compliance with local and international regulations.
• Implement continuous improvement initiatives to enhance batch release efficiency and effectiveness.

Skills

QA & GMP

Batch records review

Regulatory compliance

Cross-functional collaboration

Attention to detail

MS Excel

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Microsoft Word

Job description

Sanofi in Swiftwater, PA seeks a QA Release Senior Quality Reviewer to provide quality oversight of the Batch Release Protocol process and final release to market. You will review and approve batch release protocols for foreign and domestic submissions, ensuring GMP compliance.

You will collaborate with regulatory affairs, supply chain, and audits, driving continuous quality improvements and supporting regulatory inspections to uphold product quality and patient safety.