JOB OBJECTIVES AND SCOPE
The Base Process Technician is responsible for the aseptic processing of donated musculoskeletal human tissue to produce high quality bone and soft tissue final 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.
ESSENTIAL DUTIES AND 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 Finished Goods Specifications utilizing band saws and surgical instruments.
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 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)
Senior Process Technician, Base
Performs all duties as listed above.
Assists Supervisor(s) and Team Leaders(s) on cross training initiatives.
Will train Process Technicians on a given process.
Assists with training, training documentation and competency of other technicians and new hires.
Assists with area and processing observations for competency evaluation and verification.
Advanced Process Technician, Base
Performs all duties listed above.
Works with Engineering & R&D on new process/project.
May act as back-up to Team Leader in their absence.
Assists training function with appropriate training and competency regarding new processes.
MINIMUM JOB REQUIREMENTS
High School Diploma. College course work in the life sciences will be helpful.
Production experience in one of the following: tissue banking, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing, ISO controlled environment.
Specific Licenses and/or Certifications:
Specialized Knowledge, Skill, and Abilities*:
Fluent in the English language. Good communication, interpersonal and documentation skills. Hand tool usage and craftsman-like skills. Ability to enter data (computer/paperwork), review documents for accuracy, follow procedures closely.
Aseptic environment with potential biological hazardous and disinfection materials.
Employee is required to work in the Clean Room wearing a sterile gown, hood, boots, mask, gloves, goggles and apron for up to four hours without a rest break. Able to lift up to 40lbs and work standing up for extended periods.
Associated or Bachelor degree in sciences.
Tissue Banking, Medical Device or Hospital experience.
Specific Licenses and/or Certifications:
Surgical Assistant or similar certificate.
Specialized Knowledge, Skill, and Abilities:
Human Anatomy. Aseptic technique. Human tissue processing and surgical skill. Current Good Manufacturing Practices (cGMP’s – FDA Code of Regulations 21 CFR Part 210 & 211), Current Good Tissue Practices (cGTP’s – FDA Code of Federal Regulations - 21 CFR Part 1271).