Cleanroom, Documentation, Fast Food, Operations Processes, Patient Safety, Purchasing/Procurement, Time Management
LOCATION
Wichita, KS
POSTED
30+ days ago
This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13550114 About the Job The Cleanroom Fill Technician will assemble finished sterile products with a focus on patient safety and quality; ensures that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked. Key Responsibilities - Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines. - Cleans the equipment in the clean room daily; ensures equipment validations are up to date. - Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation. - Takes inventory in the clean room to identify components needed to fill production batches, as scheduled. - Ensures all components entering the clean room are sterile. - Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room. - Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs. - Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers. - Validates that garbing standards have been followed on a semi-annual basis. - Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months. - Follows standard operation procedures to package sterile products in their final container closure. - Designate people and hoods for different tasks. - Uses appropriate process to establish sterility on products received via pass through from compounding. - Clock in and out for every scheduled shift in a timely manner.