Sr QA Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

2d•$78,700 - $128,700•Onsite

About The Position

Regeneron is currently looking for a Sr Quality Assurance Specialist position. This position performs and leads activities “on the floor” in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Requirements

Bachelor’s degree and 6+ years of relevant experience. May substitute proven experience for education requirement.
Understanding of biologics manufacturing operations
Organized and have an attention to detail
Able to prioritize multiple assignments and changing priorities
Able to stand for periods of time when performing tasks on the floor

Nice To Haves

Excel in a quality driven organization

Responsibilities

Represent Quality Assurance in support of complex and/or significant 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; liaise with external partners and provide input on regulatory communication
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
Review, edit, or approve Regeneron controlled documents
Review and approve investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Supervising direct reports
Participates with employee training to ensure that all requirements are met.
Performs, minimally, monthly performance feedback meetings with direct reports.