Quality Assurance Specialist (External Filling)

About the role

Regeneron is seeking a Quality Assurance (QA) Specialist to focus on 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.

Location: East Greenbush, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel percentage: 5% domestic

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

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.

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• Competitive and comprehensive total rewards package which may include, depending on country and role:
  • 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
  • Family support benefits

Pay

Salary Range (annually): $67,400.00 - $128,700.00