Job Description

Summary:

Conduct cleaning and disinfection tasks in compliance with Good Manufacturing Practices (GMP), as well as perform environmental monitoring within controlled settings. These activities are essential both prior to and after 1manufacturing and research operations.

Must Have Qualifications:

• 1-3 years of experience in cleaning and disinfection services within controlled clean room environments.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Experience in aseptic procedures.
• Experience in Environmental Monitoring.
• Knowledge of cleaning and disinfection techniques and usage of related equipment in a pharmaceutical setting.

Essential Duties & Responsibilities:

Includes the following:

• Execute cleaning and disinfection tasks within controlled environment manufacturing zones (such as clean rooms), ensuring adherence to current Good Manufacturing Practices (cGMP), and regulations set by US and international regulatory bodies.
• Oversee the upkeep of assigned areas in compliance with cGMP, including cleaning of ceilings, walls, floors, doors, drains, windows, and other general surfaces.
• Adhere to written standard operating procedures to meet cGMP requirements for cleaning and disinfection of controlled clean room environments.
• Accurately document the completion of facility cleaning/disinfection as mandated by SOP.
• Respond promptly to urgent cleaning service requests, such as microbial decontamination and facility cleaning and disinfection, during and outside of regular work hours.
• Ensure cleaning equipment is well-maintained, manage cleaning/disinfection inventory, and keep storage areas for cleaning supplies and equipment tidy and safe.
• Follow written standard operating procedures to meet cGMP requirements for conducting environmental monitoring sampling of facilities, equipment, and utilities in controlled clean room environments.
• Stay informed about EM clean room equipment and techniques, such as Climet particle counter, viable airborne monitoring (active and passive), total airborne particulate sampling, viable surface monitoring, and personnel monitoring.
• Ensure the application of proper aseptic technique during the execution of EM-related tasks.
• Accurately document and submit environmental monitoring samples to testing facilities as required by SOP.
• Review environmental monitoring data for accuracy and compliance with specifications, reporting discrepancies to the supervisor.
• Support autoclaving and automated parts wash activities for Manufacturing Operations.
• Ensure comprehensive training is provided to confidently and consistently perform assigned tasks.
• Promote safety rules and awareness actively. Demonstrate good safety practices at all times, including the appropriate use of protective equipment. Report and take initiative to rectify safety and environmental hazards.
• This position may necessitate mandatory overtime to support clean room operations during holidays, weekends, and/or late and early production shifts, as needed.

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