Staff Quality Control Lab Operations Specialist

Job Overview Quality Control External Testing is looking to fill a Staff QC Lab Operations Specialist position with a 1st shift, Monday-Friday, 8:00am – 4:30pm schedule. This position performs data review of analytical test results to support QC External Testing operations. Responsibilities Provide oversight, lead, and manage the data review function within QC External Testing, establishing priorities and workflow processes to maximize efficiency and quality outcomes. Conduct comprehensive data review for Release, In-Process, and Stability testing in Advanced Therapies, ensuring adherence to quality standards. Perform thorough evaluation of analytical test method Qualification, Verification, Transfer, and Validation documentation. Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through meticulous review processes. Verify analytical data meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). Monitor testing compliance with established laboratory procedures, test methods, and approved protocols. Collaborate with laboratory personnel to address documentation errors and omissions while fostering a cGMP-oriented culture. Demonstrate exceptional attention to detail, focus, and multitasking capabilities when reviewing complex analytical laboratory data. Apply strong technical expertise in various analytical methodologies including liquid chromatography, pH measurement, iCIEF, ELISA, SEC, and CE‑SDS. Engage with team members to implement continuous improvements to data review processes and methodologies. Provide strategic guidance to QC analysts for enhancing Good Documentation Practices within cGMP frameworks and applicable SOPs. Complete assigned tasks within established timeframes while managing organizational responsibilities including tracking open tasks and timelines. Support the development and review of QA events, deviations, and investigations as required. Maintain effective communication with QC Analysts, Group Leaders, and departmental managers to ensure seamless operations and quality compliance. Qualifications You have management / supervisory experience. You can effectively communicate issues and ideas with direct reports, peers, and with management. You have a strong ability to achieve thoroughness and accuracy when performing tasks. You have strong prioritization / organizational skills and are detailed‑oriented. You have the capability to adjust to shifting priorities, manage multiple tasks and meet deadlines. You have excellent written and oral communication skills. You have experience in a GMP setting. Education and Experience Must have a BS/BA in a scientific field or an equivalent combination of education and experience. Staff Specialist level requires a BS/BA in a scientific field and 10 years of related experience or equivalent combination. Level is determined based on qualifications relevant to the role. Salary $108,000.00 – $176,000.00 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 maternity 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. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc