Quality Assurance Specialist (External Filling)

Regeneron Pharmaceuticals • Valley, AL

2d • $67,400 - $128,700 • Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a Quality Assurance (QA) Specialist to focus on our external filling operations. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Requirements

• B.S in life sciences or related field; may substitute proven experience for education requirement
• Quality Assurance Specialist: 4+ years of experience
• Senior Quality Assurance Specialist: 6+ years of experience
• Level will be determined based on experience

Responsibilities

• Reviews and approves executed batch records from external drug product filling sites
• Reviews and approves master batch records from external drug product filling sites
• Represents Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaises with external partners and provides input on regulatory communications
• Trains and/or mentors junior employees, including providing insights and education on processes and procedures
• Provides consultation and advice in alignment with QA policies
• Performs activities associated with disposition of raw materials and product (receipt, inspection, document review, shipping), on the floor or at a desk
• Reviews, edits, or approves Regeneron controlled documents
• Participates in investigations associated with raw materials or product
• Performs status labeling of product
• Continually evaluates Regeneron processes and procedures with an eye toward continuous improvement

Benefits

• Student loan paydown program
• tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off

What This Job Offers

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