QC Scientist

QC Scientist

QC scientist works in a cGMP environment performing quality control testing for commercial diagnostics products. Responsibilities include inspection and testing of products to approved specifications according to approved processes and procedures. Works closely with the manufacturing team to maintain production schedule, elevate quality issues, and ensure quality of production batches. Performs all duties using quality mindset and safety conscious practices.

Primary Duties:

1. Conducts routine QC testing of incoming raw material, finished goods, and stability products.

2. Manage QC testing schedule alongside production schedule to ensure timely closure of work orders.

3. Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.

4. Reviews production batch records and QC test results for accuracy, completeness, and GDP.

5. Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.

6. Analyzes, prepares, and communicates data findings, trends, non-conformances, and deviations.

7. Assists as needed with investigations to determine root cause of non-conformances.

8. Maintain lab equipment compliance by ensuring preventative maintenance and calibrations are completed on time.

9. Supports environmental monitoring of production spaces.

10. Performs subculture of organisms required for testing, ensuring organism availability.

11. Run instrumentation including, but not limited to UV-Vis and FTIR spectrophotometers, and microbiological diagnostic equipment.

12. Maintains inventory and orders lab supplies as needed.

13. Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.

14. Updates QC procedures and/or specifications as needed.

15. Ensures cleanliness of QC laboratory

16. Trains new team members as needed.