at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The Hazardous Drug (HD) Aseptic Technician will assemble finished sterile products with a focus on patient safety and quality. These tasks include compounding and aseptic filling of hormone and chemotherapy products in an aseptic environment.
Responsibilities:
• Responsible for the manufacturing of potent and hazard drugs.
• Must qualify for respirator and aseptic gowning.
• Works with hormone and chemotherapy products.
• 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.
• Performs necessary environmental monitoring sampling.
• 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.
• Documents batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
• Completes media fills with a set minimum of syringes and vials that is established by the quality department within a defined time frame.
• Follows standard operation procedures to package sterile products in their final container closure.
• Clock in and out for every scheduled shift in a timely manner.