Quality Control Microbiologist - Biofire

1. Complete initial data review of lot performance for finished good lots
2. Responsible for assigned lot updates, including database entries
3. Complete initial review of investigation use only (IUOs) and adhesive kit match (AKM) lots
4. Performance testing per procedure and schedule (as needed)
5. Troubleshoot performance testing issues with assistance from management. Perform failure analysis to determine preliminary cause of problem (as needed)
6. Initiates Nonconformance reports (NCs) and QC Investigations (QCIs) as needed
7. Investigates QC Investigations (QCIs) as needed
8. Follow lot through all testing and move lot to data verification following cycle time requirements – including lot partner’s lots
9. Setup AKM lots per procedure
10. Supports organism subculturing
11. Supports Environmental Monitoring
12. Takes ownership of a product line for shelf life testing and see through to completion
13. Supports Continuous Improvement within team (Lean, 5S, GEMBA)
14. Support product and process improvement, and engages in special projects as needed in QC and other areas

                    15. Ensures quality records are accurately completed and maintained   

Requires a 4-year degree in biology or related field. Work experience will not be accepted in lieu of degree. 

• Must have a minimum 3 years microbiology lab experience; or VITEK 2 operational experience.
• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
• Must have a working knowledge of antibiotic / microorganism interactions and GMP compliance.
• Must be able to demonstrate flexibility in responding to unexpected demands.  Must also be able to work in team environment, building effective working relationships