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