Quality Control Microbiologist

4 weeks ago


Hazelwood, United States Biofire Diagnostics Full time

* Complete initial data review of lot performance for finished good lots
* Responsible for assigned lot updates, including database entries
* Complete initial review of investigation use only (IUOs) and adhesive kit match (AKM) lots
* Performance testing per procedure and schedule (as needed)
* Troubleshoot performance testing issues with assistance from management. Perform failure analysis to determine preliminary cause of problem (as needed)
* Initiates Nonconformance reports (NCs) and QC Investigations (QCIs) as needed
* Investigates QC Investigations (QCIs) as needed
* Follow lot through all testing and move lot to data verification following cycle time requirements - including lot partner's lots
* Setup AKM lots per procedure
* Supports organism subculturing
* Supports Environmental Monitoring
* Takes ownership of a product line for shelf life testing and see through to completion
* Supports Continuous Improvement within team (Lean, 5S, GEMBA)
* 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



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