QA Investigation Specialist

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. Typical Day In this role, a typical day might include the following: Independently investigating non‑conformances and preventing reoccurrences in support of manufacturing operations Preparing investigation reports that include recommendations on investigation 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 Eligibility 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 learn and utilize computerized systems for daily performance of tasks 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 Requirements To be considered for this role you must hold a Bachelor’s degree in Life Sciences, Engineering, or related field and the following minimum amounts of relevant experience for each level: Associate Specialist – 0‑2 years Specialist – 2+ years Senior Specialist – 5+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Salary Range (annually) $66,400.00 - $108,400.00 Equal Opportunity Employment 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. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc