Quality Assurance Investigation Specialist

Regeneron Pharmaceuticals•Rensselaer, NY

14d•$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. Regeneron is currently seeking a Quality Assurance (QA) Specialist to conduct investigations. In this role you will perform activities in support of dispositioning product and/or raw materials 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

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

Responsibilities

Represent quality assurance in support of complex deviations, change controls, corrective and preventive action etc. including active participation in investigation, evaluation, and problem resolution
Review and approve batch records
Communicate quality assurance procedures, collaborate closely with internal or external partners and stakeholders and provide input on regulatory communications
Train and/or mentor junior employees, including providing insights and education on processes and procedures
Provides consultation or advice in alignment with quality assurance policies
Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). activities may be on the floor or at a desk
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with raw materials or product
Perform status labeling of product