QA Specialist, Internal Bulk Batch Review

Regeneron Pharmaceuticals • Rensselaer, IN

1d • $92,200 - $150,600 • Onsite

About The Position

Regeneron is seeking a Quality Assurance Specialist to support Internal Bulk Batch Review activities within Manufacturing. The role performs activities supporting product disposition while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The position may involve work on the production floor or at a desk and includes reviewing completed batch records, supporting product disposition, and collaborating with internal departments and external partners. The level—Associate QA Specialist, Specialist, or Senior Specialist—is determined based on qualifications relevant to the role.

Requirements

• Bachelor's degree in a scientific discipline or related field; proven experience may be substituted for the education requirement.
• Relevant experience requirements depend on level: Associate QA Specialist requires at least 2 years; Specialist requires at least 4 years; Senior Specialist requires at least 6 years.
• Understanding of biologics manufacturing operations.
• Ability to work effectively in a quality-driven organization.
• Organization and attention to detail.
• Good written, verbal, and interpersonal communication skills, including the ability to interact effectively across functions.
• Ability to manage multiple assignments and changing priorities, prioritize tasks, and meet deadlines.
• Ability to learn and use computerized systems for daily tasks.

Responsibilities

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, and related matters, including participating in investigations, evaluations, and problem resolution.
• Review completed batch records and collaborate with other departments to resolve issues; communicate effectively with internal locations in Tarrytown, Raheen, and Temple, as well as external parties.
• Provide consultation or advice in alignment with QA policies.
• Train and/or mentor junior employees, providing education and insights on processes and procedures.
• Perform activities associated with product disposition, such as document review and shipping.
• Review, edit, or approve Regeneron controlled documents.
• Perform status labeling of product.
• Continuously evaluate Regeneron processes and procedures for improvement.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level