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Fagron Sterile Services Cleanroom Technician (Fill) - 3rd Shift in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13024723

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.

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.
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