Description
Position Summary:
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
- Perform physical inspections of finished goods per procedure and schedule
- Provide training, guidance, and assistance to other team members. Trains lab team to waivers
- Organism subculturing
- Schedule work tasks for department team members, ensuring deadlines are met
- Troubleshoot instrument and equipment issues, perform root cause analysis as appropriate
- Initiate/Investigate Nonconformance reports (NCs) for Human Error and Physical Inspection failures
- 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
- Label cages with product disposition
- Manage Reserve Samples
- Environmental Monitoring
- Support calibration program for the lab. Performs investigations and is contact for OOT equipment
Minimum Qualifications:
- Bachelor’s Degree in Biology, or other equivalent discipline with 0 years of laboratory or manufacturing experience
- Associate's Degree and 4 years of laboratory or manufacturing experience
- High School degree and type: 8 years laboratory or manufacturing experience.
- Must have a strong knowledge of antibiotic / microorganism interactions and GMP compliance (6 months)
- Must have a minimum of six months progressively responsible lab experience (including independent project management or equivalent experience)
- Ability to remain in stationary position, often standing, for prolonged periods.
- Ability to ascend/descend stairs, ladders, ramps, and the like.
- Ability to wear PPE correctly most of the day.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
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