The Processing Technician I is responsible for producing allografts used by surgeons in implantation procedures in accordance with company Standard Operating Procedures, AATB Standards, FDA Regulations, and all applicable Federal, State, and local laws. The Processing Technician will participate in all stages of Processing including but not limited to initial processing, down streaming, sterilization and packaging.
Key Interactions and Relationships
Daily verbal and written communication with Supervisor and Production Leadership to ensure daily production goals are understood and executed according to plan and according to SOP’s, cGTP and other applicable regulations.
Regularly work in an independent and team setting maintaining professional communication with all PTT associates.
Essential Duties and Responsibilities
Complete work assignments to meet production goals in a clean room environment.
Comply with FDA, AATB, OHSA, cGTP, and state rules and regulations and PTT policies and procedures at all times.
Document all steps performed throughout the manufacturing process on approved forms in a timely manner, according to set deadlines, using Good Documentation Practices.
Responsible for packaging, labeling, and preparing final product for distribution.
Maintain constant communication with management on production status and issues.
Assist in tracking use of materials and supplies to ensure adequate inventory levels are available to support production, communicate when inventory levels are low.
Responsible for assisting in the documentation of process deviations from standard operating procedures and reporting all deviations to Regulatory Affairs/Quality Assurance and Production Supervisor for investigation.
Responsible for setting up the clean room for each process as well as turning over clean room after the completion of each process, this includes mopping, sterilization of area using approved reagents and other cleaning tasks.
Responsible for the maintenance and cleaning of instruments, clean room space, and equipment used in production; May include terminal cleaning.
Learn and develop skills in all areas of manufacturing stages including freeze-drying, sterilization, packaging and other areas of production.
Recommend process improvements to supervisor as it relates to process, SOP’s and or work instructions.
Complete all necessary safety, job specific training, and retraining on an annual basis.
Other tasks as assigned by direct supervisor and/or PTT leadership which may include assisting with special projects, documentation audits, performing inventory, and other general office duties.
Knowledge, Skills, and Abilities Required
Production and Processing — Knowledge of materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of products.
Manual Dexterity — The ability to quickly move the hand, the hand together with the arm, or two hands to grasp or manipulate objects.
Arm-Hand Steadiness — The ability to keep the hand and arm steady while moving or while holding the arm and hand in one position.
Near Vision — The ability to see details at close range (within a few feet of the observer).
Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
Perceptual Speed — The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.
Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
Critical Thinking — The ability to analyze and evaluate information gathered from, or generated by, observation, experience, reflection, reasoning, or communication in order to form a judgment.
Problem Sensitivity and Problem Solving— The ability to tell when something is wrong or is likely to go wrong and taking action to prevent or solve the problem. Operation and Control — Controlling operations of equipment or systems.
Quality Control Analysis — Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Troubleshooting — Determining causes of operating errors and deciding what to do about it.
Time Management — Managing one's own time and the time of others.
Physical Environment & Working Conditions
Full Time position (40 hours or more) based in Arizona. Hours may include evenings and weekends.
Duties are such that there will be contact with human tissue and bone which may be considered infectious; use of PPE is required in all work areas.
Duties are such there will be regular use of reagents in a controlled environment, use of PPE and adherence to safety data sheets is required.
Technicians work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required.
Work requires standing for long periods of time. Exertion of up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Work requires repetitive motion; substantial movements (motions) of the wrists, hands, and/or fingers.
Equipment & Machines Used
Band saw, surgical instrumentation, autoclave, lyophilizer, moisture analyzer, heat sealer, sonicator, microscope, centrifuge, controlled rate freezer, cryo mill, and calipers.
Desktop computer and general office equipment.
The Processing Technician I is expected to maintain confidentiality of all donor/recipient information.
Education and Work Experience Required
Associate’s degree or vocational training in surgical technology including coursework in anatomy, biology, medical terminology, sterilization techniques, and related topics or comparable work experience.
Minimum of 1-2 year’s biologics manufacturing experience working in a clean room environment using aseptic technique is preferred.
Experienced in all levels of manufacturing states including freeze drying, sterilization, DBM, and packaging, is preferred. General experience in cellular biology techniques such as cell counting is preferred.
Founded in 2010, Pinnacle Transplant Technologies (PTT) recognized the need to establish a processing and distribution facility that would enable medical professionals to acquire safe quality allograft tissue for transplant. The company manufactures innovative allografts produced to the highest standards of quality and safety. With a dedication to customer service, we are devoted to being the most responsive and accommodating Tissue Bank in the industry. Learn more about our specific products.
Pinnacle Transplant Technologies is a multi-service tissue bank dedicated to the ethical participation in the Donate Life ™ process. U.S. Food and Drug Administration (FDA) registered and American Association of Tissue Banks (AATB) accredited, Pinnacle only works with federally chartered Organ Procurement Organizations (OPOs) and agencies accredited by AATB to help provide superior allografts for transplantation, assure transplant patient safety, safeguard our associates, and assure reverence to our donor families.