Job Title: cGMP Cleaner
Location: Frederick, MD 21704
Duration: 4+ Months (Possibility of Extension Depending Upon Business Requirements and Performance)
Hours: 5x8-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
Description
- The Organization is a cell therapy company 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 The Organization'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
- Perform sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor.
- Perform sterile and non-sterile stocking, staging, and shifting (FIFO) of usable garments for multiple gowning rooms.
- Maintain accurate and complete records.
- Attend and complete all training required by Company SOPs, procedures, and policies.
- Maintain accurate and complete inventory of cleaning supplies, ensuring supplies are never depleted.
- Review and provide signatory signoff of documentation.
- Provide accurate and complete assistance to other departments as needed.
- Work 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 room.
- 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 Break Down (by %): 75% Cleaning, 15% Documentation, 10% Other Duties as Assigned.
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