Description

• 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