Processing Technician, Cellular Therapy
About The Position
This position is responsible for performing processing, cryopreservation, and testing of the hematopoietic progenitor cell products and parathyroid tissue for hospital clients. The role involves facilitating the receipt of cellular therapy products, processing various cell types and tissues following aseptic techniques, performing calculations related to cell concentrations and dosages, and preparing samples for testing and shipment. The technician will also be responsible for preparing units for shipment to transplant centers, ensuring compliance with regulatory standards, performing quality control on laboratory equipment, and maintaining accurate documentation and inventory. This role requires adherence to Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue Practices, as well as standards set by accreditation agencies. The technician will also ensure patient charts are complete and data is accurately entered into the laboratory computer system.
Requirements
- Bachelor Degree in Medical Technology, Biology, Chemistry or Physical Science.
- 0 to 2 years’ experience working in Cellular Therapy, Clinical or Research laboratory.
- Good Manufacturing Practice guidelines for cell therapy clinical trials.
- Knowledge of processing, purging, cryopreserving, thawing, and preparing cellular therapy products for infusion/transplantation.
- Aseptic/sterile technique.
- FDA and NYSDOH regulations and AABB and FACT standards.
- Working knowledge of computerized systems.
- Working knowledge of quality control procedures.
- A variety of software applications (Microsoft Office Suite).
- Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
- Skill in pipetting.
- Attention to detail in all work processes.
- Demonstrated critical thinking and troubleshooting skills.
- Mathematical skills necessary to calculate cell concentrations.
- Ability to learn scientific processes in an expedient manner.
- Ability to follow protocols to maintain quality systems.
- Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings.
- Ability to interact with individuals at all levels of the organization and customers in a helpful, courteous and friendly manner while demonstrating sensitivity to and respect for diverse populations.
- Ability to plan and organize job tasks or resources in an efficient manner.
- Ability to be responsive and available to management in order to address issues and concerns as they arise.
- Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to follow HIPPA regulations for donor/sample security.
- Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.
Responsibilities
- Performing processing, cryopreservation, and testing of hematopoietic progenitor cell products and parathyroid tissue.
- Facilitating receipt of cellular therapy products by reviewing forms, communicating with client transplant centers, and scheduling transport.
- Processing HPC, Apheresis, HPC, marrow and parathyroid tissue using aseptic technique, including cell and volume reduction and cryopreservation.
- Performing calculations for cell concentrations, dilutions, dispensing doses, volumes, and viabilities.
- Receiving and accessioning cellular therapy products.
- Preparing samples for testing, entering IDs into the electronic system, and packing samples for shipment.
- Preparing units for shipment to the transplant center, including preparing labels, reports, and shipping containers.
- Retrieving products from storage, confirming identity, packing products, and releasing them to couriers.
- Ensuring compliance with FDA, NYSDOH regulations, AABB and FACT standards, and other applicable requirements.
- Performing daily, weekly, monthly, and annual QC on laboratory equipment and freezers.
- Assisting in maintaining accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue practices regulations, and standards from FACT, FACT/Netcord, CAP, CLIA.
- Documenting deviations and events and notifying appropriate personnel.
- Ensuring patient charts contain all necessary documents and lab reports.
- Accurately maintaining and entering data in the laboratory computer system (e.g., excel spreadsheets and Stem Soft software).
- Obtaining patient test results from other laboratories.
- Maintaining accurate inventory of laboratory supplies.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
