Quality Assurance Coordinator (FT) - Transplant and Cellular Therapy Lab
About The Position
The Quality Assurance Coordinator maintains the Quality Management System in compliance with FDA regulations and FACT, AABB, CAP, Joint Commission, state, and other applicable standards. The role coordinates quality assurance programs for Cellular Therapy, Therapeutic Apheresis, and the Blood Donor Center; directs quality assurance and improvement actions for Transfusion Medicine; and develops, implements, and documents activities to maintain and improve laboratory quality assurance. The coordinator maintains departmental policies and procedures, including keeping the Policy and Procedure Manual current with cell therapy partner requirements and maintaining research and FDA-approved cellular therapy and CAR-T cell therapy protocols. The position compiles and reviews quality metrics, supports staff education and training records, documents deviations, serves as a resource on regulatory and quality matters, and prepares reports for Laboratory Administration and Hospital PI Committees. The role collaborates with the Nurse Supervisor and Charge Nurse to support adherence to policies, procedures, and protocols.
Requirements
- Bachelor’s degree in Medical Laboratory Science, Nursing, or a related field.
- Five years of experience in a related field.
- Educate staff and maintain training records on FACT, AABB, FDA, and CAP requirements.
- QLS – Qualification in Laboratory Safety from the American Society for Clinical Pathology, or an RN license in Pennsylvania.
- Ability to lift and carry 40–50 pounds; the description also identifies pushing/pulling patients and lateral transfers as examples of physical demands.
- Frequent to continuous standing and walking; patient-care providers may need to kneel, bend, squat, or perform CPR, as applicable to their role.
Responsibilities
- Coordinate Cellular Therapy, Therapeutic Apheresis, and Blood Donor Center Quality Assurance Programs.
- Maintain departmental policies and procedures and keep the Policy and Procedure Manual up to date with cell therapy partner requirements.
- Ensure laboratory compliance with standards established by CAP, Joint Commission, the state, FACT, AABB, and other regulatory agencies.
- Maintain research and FDA-approved cellular therapy and CAR-T cell therapy protocols.
- Compile and review quality assurance metrics for stem cell and cell therapy collections, donor center collections, and therapeutic apheresis procedures.
- Educate staff on FACT, AABB, FDA, and CAP requirements and maintain training records.
- Prepare reports documenting laboratory quality assurance activities for review by Laboratory Administration and Hospital PI Committees.
- Collaborate with the Nurse Supervisor and Charge Nurse to support adherence to policies, procedures, and protocols.
- Document deviations from procedures and protocols.
- Serve as a resource for staff regarding regulatory requirements and quality activities.
- Interact with coworkers, visitors, and other staff consistent with Jefferson's values.
Benefits
- Medical insurance, including prescription coverage
- Supplemental insurance
- Dental insurance
- Vision insurance
- Life and AD&D insurance
- Short- and long-term disability insurance
- Flexible spending accounts
- Retirement plans
- Tuition assistance
- Voluntary benefits, including group insurance rates and discounts
- Tuition discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service
- Medical insurance access for all colleagues, including those working less than part-time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
