Lab QC Analyst

Posted: 11/02/2020

Summary:
 
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
 
Responsibilities:
  • 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.
 
Qualifications:
  • 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.

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