QA Investigation Specialist

We are currently looking to fill a QA Investigation Specialist position within our Bulk Drug Substance Manufacturing Quality Assurance team. This role performs all compliance related tasks essential for completing investigations and implementing robust corrective actions that support manufacturing operations. Responsibilities Independently investigate non-conformances and prevent reoccurrences in support of manufacturing operations. Prepare investigation reports that include recommendations on findings for medium/high severity non-conformances. Analyze and evaluate information captured through investigations, summarizing information and trends in reports. Communicate findings and recommendations at group meetings. Review completed batch records and logbooks in accordance with cGMP standards in support of investigations. Review, edit, and revise controlled documents (batch records, logbooks, SOPs, etc.) to ensure compliance with written procedures. Monitor production processes to acquire vital data that supports investigations and tracks the efficacy of changes. Participate in or lead cross-functional study teams to obtain results, support, and/or author investigations. Collect, trend, and analyze process-related data to drive consistency and timeliness. Document all training and train new employees on investigative processes and techniques. Coordinate and/or lead cross-functional meetings with multiple departments. Qualifications Excel in a quality-driven organization. Have an understanding of biologics manufacturing operations. Be organized and detail-oriented. Prioritize multiple assignments and adapt to changing priorities. Learn and utilize computerized systems for daily task performance. Wear full cleanroom attire and remove jewelry, makeup, and nail adornments as required. Education and Experience Applicants must hold a Bachelor’s degree in Life Sciences, Engineering, or a related field. Experience requirements per level are as follows: Associate Specialist – 0 to 2 years Specialist – 2 or more years Senior Specialist – 5 or more years If you are qualified, you may apply; Regeneron is an equal opportunity employer and provides reasonable accommodations for known disabilities or chronic illnesses during the recruitment process.We are committed to building an inclusive workplace. #J-18808-Ljbffr SwiftCruit