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 continuous QA guidance to stakeholders and supports product and process quality activities. It also includes supervising direct reports, participating in employee training, and holding monthly performance feedback meetings with direct reports. The level will be determined based on experience.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• For Principal QA Specialist level: at least 6 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 remove jewelry, makeup, and nail adornments when wearing cleanroom attire.
• 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.

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 and/or significant Deviations, Change Controls, CAPAs, and related activities, including participating in investigation, evaluation, and problem resolution.
• Represent QA with external partners, communicate QA policies and procedures, liaise with partners, and provide input on regulatory communication.
• Train and mentor employees by providing process and procedure education and conveying expectations of the QA organization.
• Provide ongoing QA consultation and guidance to stakeholders on the floor regarding events and questions.
• Perform activities supporting product disposition, including manufacturing record, document, 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.
• Hold performance feedback meetings with direct reports at least monthly.

Benefits

• Annual bonuses or other incentive plans may be included, depending on country and role.
• Equity awards may be included, depending on country and role.
• Pension or retirement benefits may be included, depending on country and role.
• 401(k) company match may be included, depending on country and role.
• Health and wellness programs may be included, 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 included, depending on country and role.
• Paid time off may be included, depending on country and role.
• Family support benefits may be included, depending on country and role.

What This Job Offers

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