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Process Technician, Specialty Spine(2nd Shift)

Overview/Risks

The Specialty Spine Process Technician is responsible for the aseptic processing of donated musculoskeletal human tissue to produce high quality bone and soft tissue products to be used for implantation. This position requires the technician to disinfect and maintain an aseptic production environment as well as to work with potential biologic hazardous tissue/waste. The process technician is responsible for accurate documentation of any tissue processing activity as well as preventing human tissue, equipment and supplies from contamination. In addition, the technician will be responsible to work alone as well as in a team environment in the operations value chain in a 24/7 operation. This position may require mandatory overtime to meet business needs which include the scheduled workday as well as weekends.



Responsibilities


  • Reads, comprehends, and adheres to all appropriate standard operating procedures.

  • Follows the tissue bank procedures and instructions without any deviation.

  • Wears appropriate attire/PPE (personal protective equipment).

  • ?Prepares safe, quality tissue and maintains aseptic technique (practices and procedures under controlled conditions that minimize contamination by pathogens) at all times.?

  • Verifies the use of sterile supplies and equipment before use and exposure to tissue.?

  • Verifies any tissue released for processing in accordance to a corresponding work order before the tissue is passed to an aseptic production location.?

  • Follows the work order and/or designated Planning unit goals to ensure maximization of human tissue for transplant.?

  • Processes final products in accordance to the corresponding Work Instructions and Finished Goods Specifications utilizing the proper equipment.?

  • Assembles and operates tissue bank equipment and machinery in a safe manner.?

  • Legibly and accurately completes written documentation of processing activities (from beginning to end of each process) on controlled forms.?

  • Reads digital timers and/or clocks and convert standard time to military time.?

  • Reads measuring instrumentation: ruler, Micrometer, caliper, and graduated cylinders.?

  • Uses caution while working with sharps and cutting equipment and follows any necessary safety rules while processing tissue.?

  • Measures, takes samples, labels, and packages all tissue accurately and according to standard operating procedure/work instruction.

  • Prepare necessary tissue and environmental samples for testing according to standard operating procedures.?

  • Performs quality inspection review of all processed tissue and paperwork.?

  • Ensures waste is placed in the appropriate biological hazardous waste containers/bags and label and document according to procedure.

  • May work on more than one process at a time in separate locations while maintaining proper aseptic technique.?

  • Retrieves tissue from the designated location and completes the necessary log documentation for proper traceability of tissue.(exempt)(non-exempt)?

  • Transfers tissue to freezer for storage and completes necessary documentation.?

  • Prepares chemicals in appropriate ratios for processing and disinfection activities.?

  • Cleans and sanitizes clean room and equipment using chemicals including; spor-klenz, vesphene, bleach and ethanol to ensure an aseptically controlled sterile environment.?

  • Performs quality, sterility and safety observations as assigned.?

  • Attends internal and external training as assigned.?

  • Assists with special projects and perform additional duties as assigned including on call duty. (exempt)(non-exempt)





  1. Minimum two years experience in one of the following areas:


-???????? Tissue Banking, central sterile supply, or surgical technician Production experience in a sterile environment in the pharmaceutical or medical field.


-???????? Position requiring use of hand tools or procedures involving hand-eye coordination. High school degree.


-???????? College course work in the life sciences helpful. Good communication and interpersonal skills. Able to work in a team environment.


????? 2. Knowledge of cGMP?s, QSR?s and SUP?s


????? 3. Must be able to maintain a working knowledge of the Standard Operating Procedures


????? 4. Must be able to stand for long periods of time and work for up to four hours without a rest break




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