Supervisor, Quality Assurance Specialist (Overnight)

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. This Senior Quality Assurance Specialist 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 & Schedule

Location: Rensselaer, New York, United States
Work model: Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM

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 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, including conducting monthly performance feedback meetings.
• Participate in employee training to ensure all requirements are met.

Qualifications

• BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience.
• Principal QA Specialist: 6+ years of relevant experience.
• Staff QA Specialist: 8+ years of relevant experience.
• Experience with sterile drug product manufacturing, fill finish, and/or quality control testing.
• Level will be determined based on experience.

Skills

• Excel in a quality-driven organization.
• Understanding of biologics manufacturing operations.
• Organized with attention to detail.
• Ability to prioritize multiple assignments and changing priorities.
• Able to stand for periods of time when performing tasks on the floor.

Gowning and Environment

• Full cleanroom attire required (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves, and use of sanitizing agents during gowning process including IPA).
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.

Pay

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