Job Title: cGMP Cleaner
Hours: 5 × 8-hour 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
Pay Range: $25/hr. - $29.34/hr.
Description:
GMP cleaning team
Client is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.
We are seeking a highly motivated individual to join our Manufacturing organization as a cGMP Cleaner and support the startup of Client’s brand new, state-of-the-art, commercial Cell Therapy facility in Frederick, Maryland.
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 our 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 Company 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 an 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