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 op