Process Technician, 2nd Shift - Edison, United States - MTF Biologics
Description
Overview/Risks:
The Process Technician is responsible for aseptically processing human cells, tissues, and cellular and tissue-based products for transplant in a controlled and regulated medical device environment.
In addition, the Process Technician will be responsible to work independently 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 and holidays.
Monday-Friday / 3:00PM-11:00PM
Responsibilities:
- Reads, comprehends, and adheres to all appropriate standard operating procedures.
- Competent in the standard competencies in accordance with the new hire check list.
- Possess an understanding of the donor verification and check in and check out processes. (Edison only.)
- Gain Technical and MTF tissue product knowledge through participation in classroom, handson experience and LMS. Must maintain greater than a 90% completion rate for LMS training.
- Prepares safe, quality tissue and maintains aseptic technique (practices and procedures under controlled conditions that always minimize contamination by pathogens).
- Must be proficient and certified on 10% of the processes. (Edison Only) For Pennsylvania technicians see the Tech Level Guidance document.
- Assists the processing team in all activities related to the semiannual and quarterly shutdowns such as CORE break down, CORE loading and CORE unloading.
- Wears appropriate attire/PPE (personal protective equipment).
- Verifies the use of sterile supplies and equipment before use and exposure to tissue.
- 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 procedures while processing tissue.
- Measures, labels, and packages all tissue accurately and according to standard operating procedure.
- Prepare necessary tissue and environmental samples for testing according to standard operating procedures as requested.
- Follows the work order and/or designated Planning unit goals to ensure maximization of human tissue for transplant.
- Performs line clearance accounting of materials provided to execute the process. 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 retrieve tissue from the designated location and completes the necessary log documentation for proper traceability of tissue.
- Processes one donor at a time in a process location and complete the appropriate cleaning process and documentation and/or data entry for the environment upon completion.
- May work on more than one process at a time in separate locations while maintaining proper aseptic technique.
- Transfer tissue to freezer for storage and completes necessary documentation as needed.
- May prepare chemicals in appropriate ratios for processing activities and cleaning solutions.
- Clean and sanitize cleanroom and equipment using chemicals including peracetic acid and ethanol to ensure an aseptically controlled sterile environment.
- Ensures supplies are used in a FIFO (first in first out) and ensures supplies are appropriately stocked.
- Perform quality and safety observations as assigned
- Enroll and complete the following Learning & Development classes in the
Service Excellence Certification Program:
Business Etiquette, and Effective Listening Skills.
- May work closely with support departments when necessary; Process Engineering, Planning, Quality Engineering, Quality Assurance, Quality Control, Facilities, Supply Chain, Chemical Operations, R&D, Donor-LogIn, P&L, and Marketing.
- Responsible for their own professional development and be accountable for own results. Attends internal and external training as assigned.
- Assists with special projects and perform additional duties as assigned.
Qualifications:
- High School Diploma/G.E.D.
- Accurately adds, subtracts, measures, and calculates ratios for liquids and powders.
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