Sr QA Specialist

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About the role

Sr, Quality Assurance Specialist (Shop Floor) Regeneron is currently looking for a Sr Quality Assurance Specialist position. 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 Schedules: • Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM   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 • Supervising direct reports • Participates with employee training to ensure that all requirements are met. • Performs, minimally, monthly performance feedback meetings with direct reports.   This role may be for you if you: • 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   Gowning and Environment: • 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   To be considered for this role you must hold a Bachelor’s degree and 6+ years of relevant experience. May substitute proven experience for education requirement. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.   Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, sp

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