Quick overview
SeniorityMid Senior
Work modeHybrid
LocationFrederick, MD, United States
Job description
We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and 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 break down (by %): 75% cleaning 15% documentation 10% other duties as assigned
• 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 break down (by %): 75% cleaning 15% documentation 10% other duties as assigned
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