QA Investigation Specialist

Job Overview We are currently looking to fill a QA Investigation Specialist position with our Bulk Drug Substance Manufacturing Quality Assurance team. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations. Responsibilities Independently investigating non‑conformances and preventing reoccurrences in support of manufacturing operations. Preparing investigation reports that include recommendations on findings for medium/high severity non‑conformances. Analyzing and evaluating information captured through investigations, summarizing information and trends in investigation reports. Communicating findings and recommendations at group meetings. Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations. Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures. Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes. Participating in and/or leading cross‑functional study teams to get results, support, and/or author investigations. Gathering, trending, and analyzing process‑related data to drive consistency and timeliness. Documenting all training. Training new employees on investigative processes and techniques. Coordinating and/or leading cross‑functional meetings with multiple departments. Qualifications 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 learn and utilize computerized systems for daily performance of tasks. Have knowledge of full cleanroom attire requirements. Gowning and Environment: Full cleanroom attire (examples may include 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. Education and Experience Bachelor’s degree in Life Sciences, Engineering, or related field. Minimum relevant experience: Associate Specialist – 0-2 years; Specialist – 2+ years; Senior Specialist – 5+ years. Substitute proven experience for education requirement if applicable. Benefits Competitive and comprehensive total rewards package may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability), paid time off, and family support benefits. EEO Statement Regeneron is an equal opportunity employer; all qualified applicants will receive consideration without regard to race, color, religion or belief, 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. Reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless undue hardship. Salary ranges are disclosed where required and final offers are determined accordingly. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)