Cleanroom Fill Technician

This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/13550114About The JobThe Cleanroom Fill Technician will assemble finished sterile productswith a focus on patient safety and quality; ensures that the clean roomremains in a state of constant cleanliness and that supplies areappropriately stacked.**Key Responsibilities** Maintains a sterile environment in the cleanroom, by garbing,cleaning the room, and behaving according to clean room proceduresthat align with CGMP practices or guidelines. Cleans the equipment in the clean room daily; ensures equipmentvalidations are up to date. Follows the tech check tech process to oversee the techniques andpractices of co-workers, including product assembly, measurements,garbing, sterile techniques, and documentation. Takes inventory in the clean room to identify components needed tofill production batches, as scheduled. Ensures all components entering the clean room are sterile. Coordinates and communicates with compounding and vial wash toobtain supplies needed to turn products; communicates within theclean room, from room to room. Documents batch records, Climents (measurements of air in the room),lumacs (log use, maintenance, and cleaning of all equipment), andcleaning 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-annualbasis. Completes 3 consecutive media fills with a set minimum of syringesand vials that is established by the quality department in anestablished time frame and in the most difficult operatingconditions to pass validation every 6 months. Follows standard operation procedures to package sterile products intheir final container closure. Designate people and hoods for different tasks. Uses appropriate process to establish sterility on products receivedvia pass through from compounding. Clock in and out for every scheduled shift in a timely manner.