Contract Quality Reviewer & Batch Release (Remote)

Regeneron Pharmaceuticals, Inc.; City of Troy (NY); Híbrido; USD 70.000 - 95.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. is seeking a Quality Reviewer / Batch Release Specialist to verify batch records and CoAs for clinical and commercial products.

You will work with regulatory leads, global teams, and distribution compliance to ensure product quality and regulatory compliance across the portfolio. The role supports QP certification processes and country-specific release requirements, with a 6‑month contract and a flexible work model including remote and on-site options at

Qualificações

• Bachelor’s degree required with life sciences focus.
• 2+ years in pharmaceutical/biotech QA/QC or regulatory affairs.
• Experience with GMP, batch records, and lot release.

Responsabilidades

• Review batch status forms and CoAs to confirm lot disposition and expiry.
• Cross-check release testing panels against specifications and filings.
• Verify manufacturing/site info aligns with regulatory dossiers.
• Identify and document CoA discrepancies and impact on release.
• Escalate blocking discrepancies to regulatory and distribution teams.
• Complete endorsement/release forms in quality systems (Veeva/LIMS).
• Maintain records of specification and filing versions for audits.
• Ensure compliance with SOPs and cGMP requirements.
• Support QP certification processes (EU/UK) and country-specific releases.

Conhecimentos

GMP knowledge

Batch record review

CoA verification

Regulatory familiarity

Cross-functional collaboration

Formação

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

Ferramentas

Veeva

LIMS

Descrição da vaga

Regeneron Pharmaceuticals, Inc. is seeking a Quality Reviewer / Batch Release Specialist to verify batch records and CoAs for clinical and commercial products.

You will work with regulatory leads, global teams, and distribution compliance to ensure product quality and regulatory compliance across the portfolio. The role supports QP certification processes and country-specific release requirements, with a 6‑month contract and a flexible work model including remote and on-site options at