Quality Assurance Specialist (Batch Record & Disposition)

Regeneron Pharmaceuticals•Valley, AL

18h•$62,355 - $110,000•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking a Quality Assurance (QA) Specialist to join our batch record & disposition team. This role performs and leads activities in support of dispositioning product while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

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