Remote Quality Reviewer & Batch Release Specialist

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); Híbrido; USD 62.000 - 103.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work option

6-month contract

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Quality Reviewer / Batch Release Specialist to safeguard product quality by verifying batch records and CoAs against specifications.

The role collaborates with regulatory leads and distribution compliance across global portfolios, supporting both clinical and commercial lot release. The position offers remote or on-site work in Rensselaer, NY, with a 6-month contract.

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 filings 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.
• Cross-check release testing panels, acceptance criteria, and release results in the CoA against approved specifications and current 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.
• Escalate blocking discrepancies to regulatory leads or distribution compliance 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.
• Ensure activities follow SOPs and cGMP requirements.
• Support QP certification processes and country-specific release requirements.

Conocimientos

GMP knowledge

Batch record review

Lot release

Regulatory filings

Quality Assurance

Educación

Bachelor's degree in life sciences / chemistry / pharmacy

Herramientas

Veeva

LIMS

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Quality Reviewer / Batch Release Specialist to safeguard product quality by verifying batch records and CoAs against specifications.

The role collaborates with regulatory leads and distribution compliance across global portfolios, supporting both clinical and commercial lot release. The position offers remote or on-site work in Rensselaer, NY, with a 6-month contract.