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Job Description
This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning policies and procedures, to maintain compliance with quality standards and FDA regulations. The incumbent plays a critical role in assuring sanitary conditions of the controlled areas are maintained, to allow for the manufacturing of biopharmaceuticals. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment are maintained. Appropriate room and equipment sanitization records are neat and accurate, and that professional behavior is always displayed within the controlled areas. The incumbent may be required to work weekends, holidays, and overtime if required. Incumbent must join Local SIEU within 90 days. Day, Swing, Grave, Weekend shifts are available. This is a full time, non-exempt position.
Essential Functions:
Perform sanitization and cleaning per governing SOPs in GMP spaces
Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
Responsible for verifying that the proper sanitization disinfectant rotation is followed and that the proper sanitization disinfectant is used for each cleaning assignment
Strictly follow Standard Operating Procedures
Responsible for completing required GMP documentation to ensure records are properly and accurately maintained
Responsible for disposal of waste from GMP manufacturing process area waste receptacles daily
Responsible for organization and upkeep of sanitization supply areas
Participate in required training on the use of sanitization disinfectants and equipment
Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE)
Performs other related duties as assigned
Skills In:
Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
Communicating clearly and concisely, both orally and in writing
Ability to read, write and understand documentation in English
Ability to work in a team environment and independently
Establish and maintain collaborative working relationships with internal and external customers
Providing excellent customer service with both internal and external customers
Current Good Manufacturing Practices (cGMP) is a plus but not required
Good Documentation Practices (GDP) is a plus but not required
Company policies and practices, including safety rules and regulations
Education and/or Experience:
High School Diploma or equivalent
Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus but not required
English usage, reading and writing
Computer experience
Attention to detail is required
Excellent attendance record
Must follow work instructions
Physical Requirements and Working Environment:
No make-up, nail polish, and/or jewelry may be worn in the GMP process areas
Incumbent is subject to extended periods of standing, walking, pushing and pulling, bending and crouching, climbing, and lifting of equipment and/or materials weighing up to 50 pounds
Continuous mental and visual attention to manufacturing functions
Continuous standing and walking throughout workday
Majority of time spent fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles and/or face shield
Working in the ancillary…