Sr QA Material Supplier Specialist (Qualification)

The QA Material Supplier Specialist - Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing. In this role, a typical day might include the following: Performing activities associated with qualification of raw materials such as development of sampling and testing protocols, review of test data, drafting summary reports, etc.; execution of sampling activities may be on the floor. Representing Quality Assurance in support of deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution. Providing guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards. Supporting and/or approving SCARs (Supplier Corrective Action Requests). Working with suppliers to obtain documentation to support closure of SCARFs (Supplier Corrective Action Request Follow-Ups). Reviewing/approving Drug Product Component Supplier-specific documentation such as Approved Supplier Approvals and TSE/BSE Assessments. Providing support to relevant departments in the utilization of Drug Product Test Components. Establishing, reviewing, and editing Regeneron controlled documents. Continuously evaluating Regeneron processes and procedures with an eye toward continuous improvement; identifying gaps in systems and developing feasible plans for correction. This Role May Be For You If You Excel in a quality‑driven organization. Are an organized individual with attention to detail. Have good written, verbal, and interpersonal communication skills and the ability to effectively interact cross‑functionally. Can navigate changing priorities. Are able to learn and use computerized systems for daily performance of tasks. Can prioritize, manage multiple tasks, and meet deadlines. Are able to lift up to 25 lbs. Are comfortable working in a warehouse environment 20% of the time. Role To be considered for this role you must hold a Bachelor’s degree and the following minimum amounts of relevant experience for each level: QA Material Supplier Specialist – 3+ years. Senior QA Material Supplier Specialist – 5+ years. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. We have an inclusive culture that provides 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! Salary Range (annually) $67,400.00 - $128,700.00 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. #J-18808-Ljbffr Regeneron