QA Specialist (On the Floor)

Regeneron Pharmaceuticals • Rensselaer, IN

5d • $67,400 - $110,000 • Onsite

About The Position

The QA Specialist performs and leads on-the-floor activities supporting disposition of products and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The role provides ongoing QA presence and guidance to stakeholders, represents QA in significant quality events, and supports product and process quality activities. The position is based in Rensselaer, New York, and follows a Sunday–Thursday, third-shift schedule from 10:00 PM to 8:30 AM.

Requirements

• BS/BA in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• For Principal QA Specialist level, 6 or more years of relevant experience.
• Experience with sterile drug product manufacturing, fill finish, and/or quality control testing.
• Ability to stand for periods of time while performing tasks on the floor.
• Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments while wearing it.

Nice To Haves

• Understanding of biologics manufacturing operations.
• Organization and attention to detail.
• Ability to prioritize multiple assignments and changing priorities.
• Ability to excel in a quality-driven organization.

Responsibilities

• Represent Quality Assurance in complex or significant Deviations, Change Controls, CAPAs, and related matters, 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 communications.
• Train and mentor employees by explaining processes and procedures and conveying QA organization expectations.
• Maintain an on-the-floor presence and provide QA consultation and guidance to stakeholders on events and questions.
• Perform activities associated with 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 performance feedback meetings with direct reports at least monthly.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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