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 identifying issues and implementing effective solutions to resolve quality control problems  

Expert knowledge of laboratory instrumentation, maintenance, qualification, and calibration procedures  

Strong understanding of method validation and transfer protocols  

Proficiency in laboratory information management systems (LIMS) and quality systems ( Trackwise , SAP,   iLearn , etc.)  

Experience with **continuous improvement and Lean initiatives**, including tracking cost and efficiency metrics, is a differentiating strength *(e.g., demonstrated revenue/efficiency performance above   target)*  

Leadership & Soft Skills  

Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards  

Excellent written and verbal communication skills  

Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements  

Ability to work effectively under pressure and manage multiple priorities  

Strong problem-solving and critical thinking capabilities  

Commitment to continuous improvement and quality excellence  

Health, Safety & Environment (HSE) — Valued Asset  

Experience serving as an **HSE safety representative or correspondent**, including conducting regular lab area inspections as preventative actions  

Demonstrated experience performing monthly **GEMBA walks** and **Satellite Accumulation Area inspections**  

Experience facilitating safety initiatives, presenting safety communications, and driving action item completion within a QC department  

Ability to provide safety metrics for department-level meetings (L1, L2, QDCI) and serve as backup to the QC HSE manager  

Strong commitment to maintaining a safe laboratory environment as a core operational priority  

Working Conditions  

Laboratory environment with exposure to chemicals and specialized equipment  

May require the use of personal protective equipment (PPE)  

Standard working hours with flexibility based on operational needs, i.e. overtime may be required   

Why choose us?    

  Bring the miracles of science to life alongside a supportive, future-focused team.      

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.      

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.      

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and   wellness programs and at least 14 weeks ’   gender-neutral parental leave.    

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.   

Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale   

Transform lives worldwide by delivering life-changing treatments anywhere, anytime.   

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race;   color ; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military   status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.   

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.