Quality Control Microbiologist

Hazelwood, Missouri

BioFire Diagnostics, LLC.
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+ 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
Date Posted: 18 April 2024
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