QA Specialist (Oligonucleotides/VLPs)

We are currently looking to fill a Quality Assurance Specialist (Oligonucleotides/Virus-like particles (VLPs)) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Responsibilities Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including VLPs and small interfering RNAs (si-RNA) Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Providing consultation or advice in alignment with QA policies Performing activities associated with disposition of raw materials and product (e.g., receipt, inspection, document review, shipping, etc.) Reviewing, editing, or approving Regeneron controlled documents Reviewing and approving investigations associated with raw materials, product, laboratory, facilities, and materials Performing status labeling of raw materials and product Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement Who Should Apply Excel in a quality driven organization Have an understanding of VLP or si-RNA manufacturing operations Are organized and have an attention to detail Can prioritize multiple assignments and changing priorities Are able to learn and utilize computerized systems for daily performance of tasks Qualifications To be considered for this role you must hold a Bachelors 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. Level is determined based on qualifications relevant to the role. 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. 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. Salary Range (annually) $62,355.00 - $128,700.00 #J-18808-Ljbffr BioSpace