Sr Quality Assurance Specialist

About the role

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.

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

Requirements

• Bachelor’s degree and 6+ years of relevant experience (proven experience may substitute for the education requirement)
• Ability to stand for periods of time when performing tasks on the floor
• Full cleanroom attire required (laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves; use of sanitizing agents such as IPA during gowning)
• Ability to remove jewelry, make‑up and nail adornments when wearing cleanroom attire

Skills

• Excel in a quality‑driven organization
• Understanding of biologics manufacturing operations
• Organized with strong attention to detail
• Ability to prioritize multiple assignments and adapt to changing priorities

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 (medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

Salary Range (annually): $78,700.00 – $128,700.00

Schedule

Work Schedule: Wednesday‑Sunday, 3rd shift, 10:00 PM – 8:30 AM