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cGMP Cleaner

Urbana, MD 21704

Posted: 09/18/2023 Employment Type: Contract Job Category: Scientific Job Number: 585362 Is job remote?: No Country: United States

Job Description


We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of a brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech I, 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)
  • Perform operations within an ISO Class clean rooms
  • Employee must be able to occasionally lift and/or move up to 40 pounds
  • Employee must be able to wear a respirator during use of certain cleaning chemicals
  • 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
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