Job Description

Provide direction to the Lab team including communicating lot status and priorities to the group and demonstrating good aseptic lab practices.  Prioritize lab tasks to ensure the schedule is met.  Assists and trains others as needed in performing and documenting testing. In addition, the position is responsible for ensuring proper documentation according to cGMP’s and current procedures.  Using good aseptic lab practices, it supports performance testing and physical inspections of finished good lots and internal use only lots through set up of VITEK2 cards, to completion.

Primary Duties

• Performance testing per procedure and schedule
• Maintain records for defect traceability and trending
• Provide training, guidance, and assistance to other team members.  Train lab team to waivers (as applicable)
• Organism subculturing and/or slurry preparation
• Schedule work tasks for department team members, ensuring deadlines are met 
• Operate, train, and support troubleshooting of instrument and equipment issues, perform root cause analysis as appropriate 
• Operating and troubleshooting of instrumentation used in performance testing
• Lead efforts to ensure continuous product and process improvement in Final QC lab (5S, Gemba)
• Provide technical writing for procedural updates and review updates before submittal to document control.
• Support QC and special projects as requested by management
• Environmental Monitoring of surface, air, water (as applicable)
• Collaboration with operations, technical teams, and validation teams
• Perform other tasks as applicable per management

Qualification and Experience

The role requires High School Diploma ,GED or equivalent and 5+ years cGMP laboratory and or medical laboratory experience.

1 year progressively responsible lab experience including independent project management or equivalent experience is preferred.

Knowledge Skills and Abilities

Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.

Written Communications - including the ability to communicate technical data in written form

Demonstrates assertiveness and confidence in the face of a challenge

Organizing work and resources efficiently to ensure smooth operations

Build and maintain positive, productive interactions with colleagues

Drive for Results: Drive for Results while successfully removing barriers

Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance

Must have a strong knowledge of antibiotic / microorganism interactions and GMP compliance (6 months)

Must have a minimum of one year progressively responsible lab experience (including independent project management or equivalent experience)  

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