Temporary Remote Quality & Batch Release Specialist

Regeneron Pharmaceuticals, Inc.; Troy (MI); Híbrido; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Temporary-Quality Reviewer / Batch Release Specialist to support clinical and commercial lot release across our global portfolio.

You will verify batch records and CoAs against specifications, collaborating with regulatory leads and distribution compliance to safeguard product quality and regulatory compliance. The role offers remote or on-site work in Rensselaer, NY, with responsibilities spanning review, discrepancy identification, and endorsement

Formación

• Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus).
• 2+ years' experience in pharmaceutical/biotech Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations.
• Working knowledge of GMP, batch record review, and lot release/disposition processes.
• Familiarity with regulatory filing structures (CTD Module 3, IMPD, IND, BLA/MAA).
• Experience with clinical trial or commercial lot release preferred.
• Familiarity with QP certification processes and global distribution compliance preferred.

Responsabilidades

• Review batch status forms and CoAs for drug substance, formulated drug substance, and drug product to confirm lot disposition, manufacturer/site, and shelf life/expiry.
• Cross-check release testing panels, acceptance criteria, and release results in the CoA against approved specifications and regulatory filings.
• Verify manufacturing/testing site information, container closure, formulation, and dosage form align with the regulatory dossier.
• Identify and document discrepancies between CoA data and regulatory filings; assess impact on lot release.
• Call out blocking discrepancies to regulators and collaborators for resolution or filing amendment.
• Complete and submit endorsement/release forms in the quality system (e.g., Veeva, LIMS).
• Maintain records of specification versions, filing versions, and prior review outcomes to support future reviews.
• Ensure activities follow SOPs, work instructions, and cGMP requirements.
• Support QP certification processes (EU/UK) and country-specific release requirements.

Conocimientos

GMP knowledge

Batch release

CoA review

Quality Assurance

Educación

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

Herramientas

Veeva

LIMS

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Temporary-Quality Reviewer / Batch Release Specialist to support clinical and commercial lot release across our global portfolio.

You will verify batch records and CoAs against specifications, collaborating with regulatory leads and distribution compliance to safeguard product quality and regulatory compliance. The role offers remote or on-site work in Rensselaer, NY, with responsibilities spanning review, discrepancy identification, and endorsement