QC Lab Team Supervisor
Description
Job Title : QC Lab Team Supervisor
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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
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Oversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plans
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Conduct routine shopfloor reviews of the laboratory to identify improvement opportunities
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Ensure accurate and timely testing of received samples according to designated perimeter
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Assist in scheduling laboratory work to meet the demands of production and operational timelines
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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
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Maintain the laboratory in compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations .
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Ensure the use of validated methods within the designated perimeter and execute any validation/transfer protocol as receiving unit .
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Investigate in a timely manner and resolve any quality control events, issues, or discrepancies from the designated perimeter .
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Implement remediation actions from findings and CAPAs (Corrective and Preventive Actions)
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Author and review quality documents as a technical reviewer, including procedure revisions, protocols, reports, change controls, CAPAs, and deviations
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Support internal and external audits through scribing, backroom documentation support, and participation in management walkthroughs for audit preparation and readiness .
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Investigate customer product complaints and conduct deviation investigations, including interpretation and reporting of results
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Assist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management .
3. Team Leadership & Development
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Manage and train laboratory staff, ensuring they follow best practices and safety guidelines
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Ensure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrix
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Foster a culture of continuous improvement and high performance
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Oversee training compliance
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Actively mentor colleagues to support professional development opportunities
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Participate in the interview and selection process for new hires, including QC production workers, salaried employees, and interns
4. Technical Operations
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Maintain laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities
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Ensure lab facilities and instruments are kept in a quality and safety status to ensure appropriate use
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Apply deep, hands-on expertise in specialized techniques including:
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**Particulate Isolation and Characterization** using optical microscopy, photographic analysis, and **Micro-FTIR**
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**FTIR (Fourier Transform Infrared Spectroscopy)* * and **SEM/EDS (Scanning Electron Microscopy/Energy Dispersive Spectroscopy)* *
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**Container Closure Integrity Testing (CCIT)**
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**BLGF Testing**
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Author technical memorandums and reports
5. Laboratory & Quality Systems
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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:
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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
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Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels
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Comprehensive knowledge of **Good Manufacturing Practices (GMP)** and regulatory requirements (FDA, EMA, ICH guidelines)
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Direct, hands-on expertise in **Particulate Isolation, Micro-FTIR, and SEM/EDS** analysis within a regulated pharmaceutical environment
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Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents
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Experience in a regulated compendial testing environment *(USP/EP/JP standards a plus)*
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Active involvement in regulatory and internal inspections and audit support activities
Technical Skills
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Advanced analytical skills with the ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement
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Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
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Expert knowledge of laboratory instrumentation, maintenance, qualification, and calibration procedures
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Strong understanding of method validation and transfer protocols
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Proficiency in laboratory information management systems (LIMS) and quality systems ( Trackwise , SAP, iLearn , etc.)
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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
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Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards
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Excellent written and verbal communication skills
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Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements
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Ability to work effectively under pressure and manage multiple priorities
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Strong problem-solving and critical thinking capabilities
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Commitment to continuous improvement and quality excellence
Health, Safety & Environment (HSE) — Valued Asset
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Experience serving as an **HSE safety representative or correspondent**, including conducting regular lab area inspections as preventative actions
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Demonstrated experience performing monthly **GEMBA walks** and **Satellite Accumulation Area inspections**
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Experience facilitating safety initiatives, presenting safety communications, and driving action item completion within a QC department
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Ability to provide safety metrics for department-level meetings (L1, L2, QDCI) and serve as backup to the QC HSE manager
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Strong commitment to maintaining a safe laboratory environment as a core operational priority
Working Conditions
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Laboratory environment with exposure to chemicals and specialized equipment
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May require the use of personal protective equipment (PPE)
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Standard working hours with flexibility based on operational needs, i.e. overtime may be required
Why choose us?
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Bring the miracles of science to life alongside a supportive, future-f