Address
Form of work- 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
