Quality Assurance Coordinator (FT) - Transplant and Cellular Therapy Lab

Thomas Jefferson University•Philadelphia, PA
•Onsite

About The Position

The Quality Assurance Coordinator maintains the Quality Management System in compliance with FDA regulations and FACT, AABB, and CAP standards. The role directs quality assurance and improvement activities for Transfusion Medicine and develops, implements, and documents activities that support and improve laboratory quality assurance. It coordinates quality programs for Cellular Therapy, Therapeutic Apheresis, and the Blood Donor Center, and maintains policies, procedures, protocols, training records, and quality reports. The coordinator also serves as a resource for staff on regulatory requirements and quality activities.

Requirements

  • Bachelor’s degree in Medical Laboratory Science, Nursing, or a related field.
  • Five years of experience in a related field.
  • Qualification in Laboratory Safety (QLS) through the American Society for Clinical Pathology, or an RN license in the State of Pennsylvania.
  • Proficiency with EPIC, SOFT, SOFTDONOR, PolicyStat, Onpoint, MediaLab, and the CAP website.
  • Ability to lift and carry 40–50 pounds.
  • Frequent to continuous standing and walking.

Responsibilities

  • Coordinate Cellular Therapy, Therapeutic Apheresis, and Blood Donor Center Quality Assurance Programs.
  • Maintain the departmental Policy and Procedure Manual and keep it up to date with cell therapy partner requirements.
  • Ensure the laboratory meets 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.
  • Prepare reports documenting laboratory quality assurance activities for review by Laboratory Administration and Hospital PI Committees.
  • Educate staff and maintain training records on FACT, AABB, FDA, and CAP requirements.
  • Collaborate with the Nurse Supervisor and Charge Nurse to ensure 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 co-workers, 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
  • Flexible spending accounts
  • Retirement plans
  • Tuition assistance
  • Voluntary benefits, including access to 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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