QA Specialist (On the Floor)

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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.

Location and schedule

Location: Rensselaer, New York, United States. Work model: Wednesday – Saturday, 1st shift, 6:00 AM – 4:30 PM.

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
• Represent 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 the QA organization
• Provide 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 evaluate Regeneron processes and procedures with an eye toward continuous improvement
• Supervise direct reports
• Participate in employee training to ensure that all requirements are met
• Perform, minimally, monthly performance feedback meetings with direct reports

Requirements

• BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience
• Principal QA Specialist: 6+ years of relevant experience
• Experience with sterile drug product manufacturing, fill finish, and/or quality control testing
• Level will be determined based on experience

Qualifications

• Excel in a quality‑driven organization
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to stand for periods of time when performing tasks on the floor

Gowning and environment

• Full cleanroom attire (examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and the use of sanitizing agents during the gowning process including IPA)
• Ability to remove jewelry, make‑up, and nail adornments when wearing cleanroom attire

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g., medical, dental, vision, life, and disability)
• Paid time off
• Family support benefits

Pay

Salary range (annually): $67,400.00 – $110,000.00 (Canada posting).