QA Batch Record Review Specialist

Regulatory Jobs; City of Rensselaer (NY); In loco; USD 62.000 - 129.000; Tempo pieno

Descrizione del lavoro

Regeneron is recruiting a Quality Assurance Specialist to support Batch Record Review activities in Manufacturing. The role ensures QA compliance with cGMPs, SOPs and Regeneron standards, contributing to fast-growing, science-driven work impacting patients worldwide.

The position involves on-site work in Rensselaer, NY with structured 2nd shift hours. You will review batch records, mentor teammates, and drive continuous improvement while collaborating across sites and functions.

Competenze

• BS/BA in scientific discipline or related field. May substitute proven experience for education.
• Assoc QA Specialist: 0 to 2 years relevant experience.
• Specialist: minimum of 2 years relevant experience.
• Sr Specialist: minimum 6 years relevant experience.

Mansioni

• Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including investigation, evaluation, and problem resolution.
• Review of completed batch records and collaboration with other departments to resolve issues, communicating with internal and external teams.
• Provide consultation or advice in alignment with QA policies.
• Train and/or mentor junior employees, providing insights on processes and procedures.
• Perform activities associated with disposition of products (document review, shipping, etc.).
• Review, edit, or approve Regeneron controlled documents.
• Perform status labeling of product.
• Continually evaluate Regeneron processes and procedures toward continuous improvement.

Conoscenze

QA in Batch Records

Deviations handling

Change Controls

CAPAs

On-the-floor collaboration

Formazione

BS/BA in scientific discipline

Descrizione del lavoro

Regeneron is recruiting a Quality Assurance Specialist to support Batch Record Review activities in Manufacturing. The role ensures QA compliance with cGMPs, SOPs and Regeneron standards, contributing to fast-growing, science-driven work impacting patients worldwide.

The position involves on-site work in Rensselaer, NY with structured 2nd shift hours. You will review batch records, mentor teammates, and drive continuous improvement while collaborating across sites and functions.