Quality Assurance Specialist (Batch Record & Disposition)

Build our future together at Regeneron, where we use science and innovation to develop life-changing medicines for people with serious diseases. This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

This position performs and leads activities in support of dispositioning product while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Responsibilities

• Represent QA in support of complex and/or significant deviations, change controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represent the IOPS (Industrial Operations Product Supply) organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on issues occurring at external sites
• Provide consultation or advice in alignment with QA policies
• Perform activities associated with disposition of product (e.g., document review, disposition pack preparation, Certificate of Analysis Review)
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with raw materials, product, laboratory, facilities, or materials
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement
• May train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization

Requirements

• B.S. in life sciences or related field; may substitute proven experience for education requirement
• Associate QA Specialist: 2+ years of experience
• QA Specialist: 4+ years of experience
• Level will be determined based on experience

Location: East Greenbush, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel percentage: 10% domestic

Benefits

Regeneron offers a 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

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, additional information will be provided during the recruitment process.

Pay

Salary Range (annually): $62,355.00 - $110,000.00