QA Specialist (On the floor)

Regeneron Pharmaceuticals • Rensselaer, IN

1d • Onsite

About The Position

Regeneron is currently looking for a Quality Assurance (QA) Specialist to join our QA Operations team. 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. Work Schedule: Sunday- Wednesday, 1st shift, 6:00am-4:30pm In this role, a typical day might include the following: Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Represents 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 Provides 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 evaluating Regeneron processes and procedures with an eye toward continuous improvement

Requirements

• 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
• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
• Bachelor’s degree and the following amount of relevant experience for each level: Associate QA Specialist - 2+ years QA Specialist - 4+ years Sr QA Specialist - 6+ years
• May substitute proven experience for education requirement.

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
• Represents 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
• Provides 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 evaluating Regeneron processes and procedures with an eye toward continuous improvement

Benefits

• comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

What This Job Offers

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