Responsibilities:
- Maintain cleanroom inventory; perform material transfers and cleanroom-required activities to support cGMP operations (e.g., restocking Kanban, scrubs, and gowning)
- Communicate with manufacturing and materials management to confirm proper materials are stocked accordingly
- Perform cleanroom setup and shutdown (e.g., biohazard waste decontamination; packaging and autoclaving of required materials/supplies)
- Perform special manufacturing projects
- Complete required documentation with proper cGMP recording on batch records, forms, and protocols independently
- Operate, maintain, and clean GMP equipment (e.g., centrifuges, microscopes, incubators, BSCs, refrigerators, freezers)
- Initiate minor revisions to existing documents to troubleshoot simple procedures and support continuous improvement initiatives
- Perform other duties as assigned
Requirements:
- High school diploma or GED required
- Lift, push, pull, and carry up to 40 lbs
- Excellent knowledge of aseptic technique and aseptic practices
- Exceptional communication and interpersonal skills; team player
- Excellent organizational skills and attention to detail
- Ability to work in a dynamic environment
- Adaptable/flexible schedule; ability to multi-task and prioritize
- Extended hours may be required from time to time; occasional weekend work may be required
Preferred:
- Bachelorβs degree in Biology, Biological Sciences, or related field
- 1+ years of experience in GMP/cGMP manufacturing environment (academic/industry)
- Excellent knowledge of Good Documentation Practices