At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.When & where:Location: East Greenbush, New York, United StatesWork model: 3rd shift, Friday-Tuesday, 10pm-8:30amWhat you’ll do:Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label teamPerform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of proceduresDevelop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.Maintain project timelines to support the evolving businessPerform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documentsReview and approval of documents (electronic and paper-based)Provide mentorship during on-the-floor manufacturingSupport audits, inspections and investigationsPerform quarantine, segregation of material and line clearancesContribute to the continuous improvement initiativesAdjust schedule based on facility start up, filling, and manufacturing needsCollaborate with cross-functional internal teamsThe environment and physical rhythms of this role:Gowning: 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 attireAbility to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environmentSome physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbsLet’s find out if we’re a fit:Requires B.S in life sciences or related field and 6+ years of experience; may substitute proven experience for education requirementLevel will be determined based on experienceThrive today. Grow tomorrow.Student loan paydown program & tuition reimbursementFamily Care BenefitsRelocation assistanceInclusion, culture and well-being programs (including physical & mental health)#REGNQADoes 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, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.For jobs in Canada: this posting is for an existing position.Salary Range (annually)$78,700.00 - $128,700.00