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. 
 

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 InfraredSpectroscopy)** and **SEM/EDS (Scanning Electron Microscopy/Energy DispersiveSpectroscopy)**

• **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:  

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 abovetarget)*

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