Gowning Room Coordinator
Fagron Sterile Services US (FSS), Wichita, KS, United States
This role is responsible for maintaining the cleanliness, organization, and inventory of controlled cleanroom areas to ensure compliance with Fagron Sterile Services GMP standards and internal SOPs. This role is critical to supporting sterile production operations, audit readiness, and the overall quality of our aseptic manufacturing environment.
Key Responsibilities
Perform Daily, Weekly, and Monthly sanitation tasks per schedule in controlled cleanroom environments and communicate effectively via Microsoft Teams to ensure full cleaning coverage across all areas.
Assist with remediation cleanings as required.
Safely handle, prepare, and apply various disinfectants in compliance with SOPs and SDS requirements.
Efficiently maintain gowning supplies (gowns, gloves, shoe covers, hair covers, face masks, etc.) ensuring they are readily available for use while following FIFO.
Perform area monitoring to ensure all cleanrooms remain free of debris; remove trash and waste promptly.
Accurately document all sanitation activities in a timely, GDP- and cGMP compliant manner.
Successfully complete garbing qualifications and maintain certification biannually.
Work within controlled environments, always maintaining aseptic techniques.
Disinfect all cleanroom surfaces (e.g., counters, shelves, CWFs) by established cleaning methodologies.
Maintain inventory of sanitation supplies (disinfectants, mop heads, sterile water, etc.) following FIFO; inspect supplies for expiration or damage and dispose of items per SOPs.
Stay informed of new sanitation SOPs and practices to continuously improve quality and efficiency.
Assist in pre-shutdown preparations and support bi-annual shutdown cleaning.
Stay current on all training assignments and SOP revisions, including required garbing requalification.
Adhere to all current SOPs and updates to maintain a continuous state of audit readiness.
Maintain consistent communication with the Supervisor to provide updates, feedback, and recommendations.
Report equipment repair needs, preventive maintenance requirements, and facility issues to the Supervisor and Facility Maintenance Engineer promptly.
Perform other related duties as assigned.
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Key Responsibilities
Perform Daily, Weekly, and Monthly sanitation tasks per schedule in controlled cleanroom environments and communicate effectively via Microsoft Teams to ensure full cleaning coverage across all areas.
Assist with remediation cleanings as required.
Safely handle, prepare, and apply various disinfectants in compliance with SOPs and SDS requirements.
Efficiently maintain gowning supplies (gowns, gloves, shoe covers, hair covers, face masks, etc.) ensuring they are readily available for use while following FIFO.
Perform area monitoring to ensure all cleanrooms remain free of debris; remove trash and waste promptly.
Accurately document all sanitation activities in a timely, GDP- and cGMP compliant manner.
Successfully complete garbing qualifications and maintain certification biannually.
Work within controlled environments, always maintaining aseptic techniques.
Disinfect all cleanroom surfaces (e.g., counters, shelves, CWFs) by established cleaning methodologies.
Maintain inventory of sanitation supplies (disinfectants, mop heads, sterile water, etc.) following FIFO; inspect supplies for expiration or damage and dispose of items per SOPs.
Stay informed of new sanitation SOPs and practices to continuously improve quality and efficiency.
Assist in pre-shutdown preparations and support bi-annual shutdown cleaning.
Stay current on all training assignments and SOP revisions, including required garbing requalification.
Adhere to all current SOPs and updates to maintain a continuous state of audit readiness.
Maintain consistent communication with the Supervisor to provide updates, feedback, and recommendations.
Report equipment repair needs, preventive maintenance requirements, and facility issues to the Supervisor and Facility Maintenance Engineer promptly.
Perform other related duties as assigned.
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