Final QC Microbiologist
Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Quality
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
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. Performs environmental monitoring of the site. 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 role will support the weekend shift with normal working hours including Friday, Saturday, and Sunday as part of the normal work schedule. Flexible start time between 6:00am - 9:00am.
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 Quality Events (QEs) 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 Adhesive Kit Match 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
- 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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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMérieux’s or its affiliates’ 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).
