The QTI Group is recruiting for a Lab QC Analyst to join our client’s laboratory operations located near Madison, Wisconsin. The QC Analyst will be responsible for the quality control processes in a GMP-compliant manufacturing facility.
Shift: Shift is likely to be Full-Time with four ten-hour shifts on Thurs, Fri, Sat, Sun OR Sat – Tuesday, 1st shift, Flexible start time between 6:00 am – 9:00 am
- Perform microbiological and analytical tests (i.e., serial dilution and bacterial cultures) on finished products, intermediate products, raw materials, R&D materials, and production equipment and facilities.
- Collect and prepare samples for testing.
- Prepare chemical and bacteriological media, reagents, and test solutions.
- Review vendor certificates of analysis (COAs) against in-house specifications and report discrepancies.
- Review incoming packaging components and labels for conformance to specifications.
- Compile test results and complete finished product and component COAs.
- Record lab test tracking data and communicate testing and release status of components and products.
- Coordinate contract lab testing and review results; assist in the qualification of contract labs.
- Perform and document lab equipment maintenance and calibration, per written procedures.
- Participate in lab instrument, method, and cleaning validations.
- Assist with writing and/or revising SOPs and Standardized Work Instructions.
- Recognize and report potential quality problems.
- Assist with QC investigations.
- Revise and/or create new test methods and specifications.
- Analyze retrieved data and prepare reports for lab management.
- Associates degree in scientific field (Microbiology, Biology, Chemistry, or related) required; Bachelor’s degree preferred.
- Minimum 6 months’ quality control or quality assurance work experience in an FDA-regulated industry; pharmaceutical or supplement industry experience is a plus. Having at least 2 years’ experience is preferred!
- Strong understanding of microbiology, chemistry, and practical application of general lab skills.
- Excellent communication, organizational, planning, problem-solving, and follow-up skills.
- Ability to handle multiple, rapidly changing priorities and handle unanticipated events without losing sight of core responsibilities.
- Demonstrated sense of urgency to initiate, complete, and communicate test results and findings.
- Work effectively as a team player in a diverse work group.
- Capable of prioritizing tasks to meet goals and ensure product quality.