Responsibilities
- Maintaining cleanroom inventory, performing material transfers and cleanroom-required activities to support cGMP operations (i.e restocking Kanban, scrubs, and gowning)
- Ensuring clear communication and working closely with manufacturing and materials management to confirm proper materials are stocked accordingly;
- Performing cleanroom setup and shutdown (Biohazard waste decontamination, packaging and autoclaving of required materials/supplies, etc)
- Performing special manufacturing projects
- Completing required documentation with proper cGMP recording of entries and comments on batch records, forms and protocols independently;
- Operation, Maintenance, and Cleaning of GMP equipment, including: Centrifuges, Microscopes, Incubators, BSCs, Refrigerators, Freezers, etc
- Initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives.
- Performing such other duties as may be assigned from time to time.
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
- Excellent organizational skills and attention to detail
- Excellent interpersonal skills, team player
- Ability to work in a dynamic environment
- Adaptable/flexible with work schedule with an ability to multi-task and prioritize work
- From time-to-time extended hours may be required with or without notice, dependent on the work needed
- Occasional weekend work may be required
Preferred
- Bachelor’s degree in Biology, Biological Sciences or related field preferred
- 1+ years of experience in GMP/cGMP manufacturing environment in academic/industry setting
- Excellent knowledge of Good Documentation Practices