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.