QC Lab Team Supervisor

Job Title :   QC Lab Team Supervisor   Location:   Swiftwater, PA   About the Job :     The Quality Control Laboratory Team Supervisor plays a pivotal role in ensuring the highest standards of product quality and patient safety within a pharmaceutical/vaccine manufacturing environment. This position is ideally suited for a seasoned QC laboratory professional who has demonstrated progressive growth through hands-on technician roles, training management, and laboratory management responsibilities. The successful candidate will bring proven expertise in quality control operations, regulatory compliance, and team leadership — with a track record of driving continuous improvement while maintaining strict adherence to internal and external GMP requirements.   Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.       About Sanofi:     We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.    Main Responsibilities :     1. Laboratory Operations Management   Oversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plans   Conduct routine shopfloor reviews of the laboratory to identify improvement opportunities   Ensure accurate and timely testing of received samples according to designated perimeter   Assist in scheduling laboratory work to meet the demands of production and operational timelines   Serve as a qualified   reviewer for   key testing areas to maintain operational continuity and testing coverage, including but not limited to: Wet Chemistry, Electrophoresis, HPLC, LCMS, CCIT, BLFG, ICP, FTIR, GC, MALs, and SEM/EDS.   2. Compliance & Quality Assurance   Maintain the laboratory in compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations .   Ensure the use of validated methods within the designated perimeter and execute any validation/transfer protocol as receiving unit .   Investigate in a timely manner and resolve any quality control events, issues, or discrepancies from the designated perimeter .   Implement remediation actions from findings and CAPAs (Corrective and Preventive Actions)   Author and review quality documents as a technical reviewer, including procedure revisions, protocols, reports, change controls, CAPAs, and deviations   Support internal and external audits through scribing, backroom documentation support, and participation in management walkthroughs for audit preparation and readiness .   Investigate customer product complaints and conduct deviation investigations, including interpretation and reporting of results   Assist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management .   3.   Team Leadership & Development   Manage and train laboratory staff, ensuring they follow best practices and safety guidelines   Ensure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrix   Foster a culture of continuous improvement and high performance   Oversee training compliance   Actively mentor colleagues to support professional development opportunities   Participate in the interview and selection process for new hires, including QC production workers, salaried employees, and interns   4. Technical Operations   Maintain laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities   Ensure lab facilities and instruments are kept in a quality and safety status to ensure appropriate use   Apply deep, hands-on expertise in specialized techniques including:   **Particulate Isolation and Characterization** using optical microscopy, photographic analysis, and **Micro-FTIR**   **FTIR (Fourier Transform Infrared   Spectroscopy)* * and **SEM/EDS (Scanning Electron Microscopy/Energy Dispersive   Spectroscopy)* *   **Container Closure Integrity Testing (CCIT)**   **BLGF Testing**   Author technical memorandums and reports   5. Laboratory & Quality Systems   Demonstrate proficiency in laboratory and quality management systems including:   ** Opstrakker ,   Qualipso ,   iLearn , SAP, LIMS ( LabWare ),   Trackwise ,* *   and the **Adobe Software Suite**   About You :     Basic qualifications: Bachelor’s degree in Life Sciences , Pharmaceutical Sciences, Engineering or a related scientific field with at least 8 years of experience in a cGMP environment.   Experience   Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels   Comprehensive knowledge of **Good Manufacturing Practices (GMP)** and regulatory requirements (FDA, EMA, ICH guidelines)   Direct, hands-on expertise in **Particulate Isolation, Micro-FTIR, and SEM/EDS** analysis within a regulated pharmaceutical environment   Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents   Experience in a regulated compendial testing environment *(USP/EP/JP standards a   plus)*   Active involvement in regulatory and internal inspections and audit support activities   Technical Skills   Advanced analytical skills with the ability to   analyze   complex data and laboratory results to make informed decisions and identify areas for improvement   Proficiency in ident