Remote Quality Reviewer & Batch Release Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; Híbrido; USD 65.000 - 95.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. seeks a Quality Reviewer / Batch Release Specialist to verify CoAs and batch records, ensuring release in line with approved specs and regulatory filings.

The role collaborates with regulatory leads and global teams to safeguard quality across clinical and commercial products. Candidates should have a life sciences degree and 2+ years' QA/QC/CMC experience, with GMP knowledge and familiarity with regulatory structures.

Qualificações

• Bachelor's degree in life sciences, chemistry, pharmacy, or related field.
• 2+ years' experience in pharmaceutical/biotech QA, QC, regulatory affairs, or CMC operations.

Responsabilidades

• Review batch status forms and CoAs to confirm lot disposition and shelf life.
• Cross-check release panels, acceptance criteria, and CoA against specifications and regulatory filings.
• Verify manufacturing/testing site information aligns with regulatory dossiers.
• Identify and document discrepancies between CoA data and filings; assess impact on release.
• Submit endorsement/release forms and maintain record versions for future reviews.
• Ensure compliance with SOPs, work instructions, and cGMP requirements.
• Support QP certification processes and country-specific release requirements.

Conhecimentos

Quality assurance

Batch release

Regulatory compliance

Formação

Bachelor's degree in life sciences, chemistry, pharmacy, or related field

Ferramentas

Veeva

LIMS

Descrição da vaga

Regeneron Pharmaceuticals, Inc. seeks a Quality Reviewer / Batch Release Specialist to verify CoAs and batch records, ensuring release in line with approved specs and regulatory filings.

The role collaborates with regulatory leads and global teams to safeguard quality across clinical and commercial products. Candidates should have a life sciences degree and 2+ years' QA/QC/CMC experience, with GMP knowledge and familiarity with regulatory structures.