Job Title: cGMP Cleaner/ Lab Tech II
Hours: 5x8 hours days, 10:30 PM – 7:00 AM (mandatory 1 weekend day a week)
Training Hours: First three weeks Monday – Friday, 7:30 AM – 4:00 PM
Location: 100% Onsite – Frederick, MD
Description
GMP cleaning team Job Title cGMP Cleaner. This is a cell therapy manufacturing environment focused on providing patients with highly effective, life-saving therapies. The facility supports commercial products as well as a robust pipeline of autologous and allogeneic clinical programs.
We are seeking a highly motivated individual to join the Manufacturing organization as a cGMP Cleaner and support the startup of a brand-new, state-of-the-art commercial Cell Therapy facility.
The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for ISO Class rooms and Controlled Non-Classified Lab Areas.
Responsibilities
- Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
- Performs sterile and non-sterile stocking, staging, and shifting (FIFO) of usable garments for multiple gowning rooms
- Maintains accurate and complete records
- Attends and completes all training required by SOPs, procedures, and policies
- Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
- Reviews and provides signatory signoff of documentation
- Provides accurate and complete assistance to other departments as needed
- Works in a safe and effective manner in accordance with all company, state, and federal rules and regulations
- Perform any other tasks/duties as assigned by management
- Embrace the QUALITY culture
Basic Requirements
- AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience
Physical Environment and Physical Requirements
- Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
- Ability to wear a respirator during use of certain cleaning chemicals
- Perform operations within ISO Class clean rooms
- Employee must be able to occasionally lift and/or move up to 40 pounds
- Must be able to squat, bend, kneel, and/or reach for 80% of a shift
- Must be able to stand, walk, and/or move about for 80% of a shift
Preferred Qualifications
- Clean room sanitization experience or cGMP operational experience a plus
Task Breakdown (by %)
- 75% Cleaning
- 15% Documentation
- 10% Other duties as assigned
Regads,
Harsha
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