[Remote] Quality Assurance Specialist (Batch Record & Disposition)
Note: The job is a remote job and is open to candidates in USA. Regeneron develops life-changing medicines for people with serious diseases and is seeking a Quality Assurance Specialist to join its batch record and disposition team. The role supports product disposition, quality investigations, document approvals, external partner communication, and continuous improvement while ensuring compliance with QA policies, cGMPs, SOPs, and standard requirements.
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
- Provides consultation or advice in alignment with QA policies
- Performs activities associated with disposition of product (e.g. document review, disposition pack preparation, Certificate of Analysis Review)
- Reviews, edits, or approves Regeneron controlled documents
- Reviews and approves 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
Skills
- 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
Benefits
- Annual bonuses or other incentive plans, depending on country and role
- Equity awards, depending on country and role
- Pension or retirement benefits, depending on country and role
- 401(k) company match, depending on country and role
- Health and wellness programs, depending on country and role
- Fitness centers, depending on country and role
- Insurance benefits (e.g. medical, dental, vision, life and disability), depending on country and role
- Paid time off, depending on country and role
- Family support benefits, depending on country and role
Company Overview
