The position will work as part of a team responsible for the quality control processes performed in a GMP-compliant dietary supplement manufacturing facility. All team members must be mindful of production timelines while supporting the achievement of quality, safety, sales and production goals.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Perform microbiological and analytical tests on finished products, intermediate products, raw materials, R&D materials, and production equipment/facilities.
- Collect and prepare samples for testing.
- Prepare chemical and bacteriological media, reagents, and test solutions used in the laboratory.
- Review vendor 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 laboratory test tracking data and communicate testing and release status of components and products in a timely manner.
- Coordinate contract laboratory testing and review results. Assist in the qualification of contract laboratories.
- Perform and document laboratory equipment maintenance and calibration per written procedures.
- Participate in laboratory instrument, method, and cleaning validations.
- Assist with writing and/or revising Standard Operating Procedures and Standardized Work Instructions.
- Recognize and report potential quality problems to management.
- Assist with QC investigations per written and verbal instructions.
- Revise and/or create new test methods and specifications that conform to company policies.
- Analyze retrieved data and prepare reports for laboratory management.
- Other QC-related duties as assigned.
The appropriate knowledge, skills and abilities required for this position are achievable through a combination of education, work experience and training, including:
- An Associates or Bachelors Degree from an accredited college/university in Microbiology, Biology, Molecular Biology, Chemistry or related field is required.
- Some Quality Control or Quality Assurance work experience in an FDA-regulated industry, preferably dietary supplements or pharmaceuticals is preferred.
- A strong understanding of microbiology, chemistry and practical application of general laboratory skills.
- Excellent communication, organizational, planning, problem-solving and follow-up skills.
- The ability to handle multiple, rapidly changing priorities and handle unanticipated events without losing sight of core responsibilities.
- Incorporate a sense of urgency for initiation, completion, and communication of testing results and findings.
- The ability to work consistent hours and be flexible enough to include occasional overtime.
- Work effectively as a team player in a diverse work group.
- Capable of prioritizing tasks to meet goals and ensure product quality.