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.