In this role you will perform all compliance related tasks necessary to complete investigations and implementation of robust corrective actions for supporting manufacturing and site operations. Provide compliance expertise throughout the Engineering, Automation & Facilities departments.As a Compliance Specialist in Technical Operations a typical day might include, but is not limited to, the following:Independently lead non-conformance investigations to prevent reoccurrencesReview Equipment Drawings, Schematics, Life Cycle Documents, and Automation programmingReview SOPs, Work Instructions, Batch Sheets, Manufacturing Records and Logbooks in accordance with cGMP standardsMonitor production processes to obtain necessary data in support of investigations and track effectiveness of changesCollect, trend, and analyze process related data to evaluate the non-conformanceLead/Perform Root Cause Analysis on Medium/High risk non-conformancesIdentify and evaluate the severity of the non-conformance, potential product impact and Corrective/Preventative actionsCoordinate, participate, and/or lead cross-functional team meetingsPrepare investigation reports that include event details, root cause analysis, product impact assessment, and Corrective Action recommendations for medium/high severity non-conformancesMaintain documents and all training in accordance with cGMP standardsMay revise controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written proceduresMay train and mentor new employees on investigation processes and techniquesMay assist in regulatory inspection preparations, act as a department liaison during regulatory inspections, and coordinate post-inspection activitiesTo be considered for this opportunity you should have a BS/BA in Life Sciences, Engineering or related field and 3+ years of relevant experience or an equivalent combination of education and relevant experience.#LI-Onsite #JOBSIEST #IRELIM #REGNIRLTODoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
