QA Specialist, Internal Bulk Batch Review

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Specialist to support our Internal Bulk Batch Review activities within Manufacturing. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
• Review of completed batch records and collaborating with other departments to resolve issues, communicating internally (Tarrytown, Raheen, Temple) and externally effectively.
• Provide consultation or advice in alignment with QA policies.
• Train and/or mentor junior employees, including providing insights and education on processes and procedures.
• Perform activities associated with disposition of products (e.g., document review, shipping, etc.). Activities may be on the production floor or at a desk.
• Review, edit, or approve Regeneron controlled documents.
• Perform status labeling of product.
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement.

Qualifications

• Requires BS/BA in scientific discipline or related field. May substitute proven experience for education requirement.
• Assoc QA Specialist: minimum of 2 years relevant experience.
• Specialist: minimum of 4 years relevant experience.
• Sr Specialist: minimum 6 years relevant experience. Level is determined based on qualifications relevant to the role.

Skills

• Understanding of biologics manufacturing operations.
• Excel in a quality-driven organization.
• Organized with attention to detail.
• Good written, verbal, and interpersonal communication skills and the ability to effectively interact cross-functionally.
• Ability to manage multiple assignments and changing priorities.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.

Pay

Salary Range (annually): $67,400.00 - $110,000.00

Schedule

Monday-Friday, 12:00 PM - 8:30 PM

Location

Rensselaer, New York, United States