Sr Final QC Microbiologist

3 weeks ago

Hazelwood, Missouri, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

Description

Position Summary: Microbiologist is responsible for review of finished good lot performance data to ensure all lots meet current specifications. Performs performance testing and additional testing for assigned lot as needed. Uses good aseptic lab practices, is responsible for timely and accurate testing of VITEK2 finished good cards to ensure they meet all defined acceptance criteria and move to data verification. This position must prioritize tasks and priority lots to ensure schedule is met. Primary Responsibilities: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 Ensures quality records are accurately completed and maintained Education, Skills, & Experience:Requires a 4-year degree in biology or related field and a minimum 3 years related microbiology lab 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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