What are the responsibilities and job description for the Quality Control Lab Technician-Plough Center position at University of Tennessee and Careers?
Market Range: 08
Hiring Salary: $21.69/Hourly
JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Quality Control Lab Technician supports all aspects of QC operations in a cGMP pharmaceutical manufacturing environment. This role performs routine and non-routine testing of raw materials, in-process samples, finished drug products, water systems (source water, process water, RO water, WFI), and environmental monitoring samples to ensure compliance with FDA, USP, and Plough Quality standards. The QC Lab Technician is responsible for accurate documentation, data integrity, investigation support, and collaboration with manufacturing, maintenance, and quality teams. The position also supports sterile manufacturing activities, product release processes, and continuous improvement initiatives that uphold product quality, regulatory compliance, and operational efficiency.
- Conducts microbiological, chemical, and physical testing of source water, RO water, and WFI systems in accordance with cGMP, FDA, and USP requirements.
- Performs routine and non-routine laboratory testing of raw materials, in-process samples, semi-finished, and finished drug products following approved SOPs, methods, and specifications.
- Executes environmental monitoring (EM) of controlled areas, including viable and non-viable sampling, surface sampling, and personnel monitoring.
- Maintains complete, accurate, and contemporaneous laboratory documentation in compliance with GDP and data integrity standards.
- Processes, prepares, and analyzes product samples using standard wet chemistry, microbiological, and instrumental methods.
- Collaborates with production, engineering, and maintenance to support investigations, troubleshooting, deviation resolutions, and continuous improvement projects.
- Supports the cleaning, sanitation, and verification of water systems and laboratory equipment, including CIP activities when required.
- Operates and maintains laboratory instrumentation, ensuring calibration, verification, and appropriate usage logs are maintained.
- Assists sterile manufacturing operations with sterile component prep, environmental monitoring, aseptic support activities, and review of batch documentation.
- Supports compounding, filling line readiness, line clearances, equipment disassembly/assembly, visual inspection, labeling, and packaging activities as needed in accordance with cGMP.
- Understands and uses production and laboratory control systems—including batching systems, LIMS, and other electronic data systems—to support manufacturing and QC operations.
- Manages multiple priorities while maintaining compliance with safety, quality, and documentation requirements.
- Participates in shipping, support activities by performing product sampling, release testing, and coordinating with other departments to ensure timely shipment.
- Performs other QC and laboratory support duties as assigned.
MINIMUM REQUIREMENTS:
EDUCATION: Bachelor’s Degree. (Bachelor’s Degree preferred.) (TRANSCRIPT REQUIRED)
EXPERIENCE: One (1) year of experience working in a test laboratory conducting analytical testing.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Excellent analytical and problem-solving skills with strong written and oral communication skills.
- Ability to follow instructions and work well with limited supervision, both individually and as a team.
- Understanding Food & Drug Safety principles and Current Good Manufacturing Practices (cGMP).
- Understanding of Good Laboratory Practices (GLPs) and aseptic sampling and handling techniques to collect samples for microbiological analysis.
- Experience operating under a quality management system or another regulated environment is desirable.
WORK SCHEDULE: This position may occasionally be required to work weekends.
Salary : $22