Quality Assurance Specialist, On the Floor

Regeneron Pharmaceuticals • Rensselaer, IN

14d • $67,400 - $128,700 • Onsite

About The Position

The Quality Assurance Specialist performs and leads on-the-floor activities that support dispositioning product and/or raw materials while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The role provides continuous QA guidance to stakeholders and contributes to investigations, product disposition, document control, employee development, and process improvement. The position may be filled at QA Specialist or Senior QA Specialist level, depending on experience, and includes supervising direct reports.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• Senior QA Specialist level: 6 or more years of relevant experience.
• QA Specialist level: 2 or more years of relevant experience.
• Experience with drug substance.
• Ability to wear full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA during gowning.
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.

Responsibilities

• Represent Quality Assurance in complex and/or significant Deviations, Change Controls, CAPAs, and related work, including active participation in investigation, evaluation, and problem resolution.
• Represent QA with external partners to communicate QA policies and procedures, liaise with partners, and provide input on regulatory communication.
• Train and mentor employees by providing education on processes and procedures and communicating QA expectations.
• Maintain an on-the-floor presence and provide stakeholders with QA consultation and guidance on events and questions.
• Perform activities supporting product disposition, including manufacturing record review, document review, and source data review.
• Review, edit, or approve Regeneron controlled documents.
• Review and approve investigations associated with products or processes.
• Evaluate Regeneron processes and procedures for continuous improvement.
• Supervise direct reports.
• Participate in employee training to ensure requirements are met.
• Conduct monthly performance feedback meetings with direct reports, at minimum.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior