Clock in and out for every scheduled shift in a timely manner.
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.
Takes inventory in the clean room to identify components needed to fill production batches, as scheduled.
Designate people and hoods for different tasks.
Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
Uses appropriate process to establish sterility on products received via pass through from compounding.
Follows standard operation procedures to package sterile products in their final container closure.
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.
Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.
Follows the "tech check tech" process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation.
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.
Validates that garbing standards have been followed on a semi-annual basis.