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Description

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

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).