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

About the role

Number of Positions In Requisition

1

Job Details

Maintain Quality Management system in compliance with FDA regulations and FACT, AABB and CAP standards. Directs Quality Assurances/Improvement actions for Transfusion Medicine. Create and maintain department policies and procedures to ensure they comply with regulatory standards. Develops, implements and documents activities relating to the QA program to maintain and improve the lab's QA. This position includes, but is not limited to the following essential functions.

Job Duties

• Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
• Coordinate Cellular Therapy, Therapeutic Apheresis and Blood Donor Center Quality Assurance Programs.
• Maintain departmental Policy and Procedure Manual to be up-to-date with cell therapy partner requirements.
• Ensure that the laboratory properly meets standards established by CAP, Joint Commission, State, FACT, AABB and other regulatory agencies.
• Maintain research and FDA-approved cellular therapy and CAR-T Cell therapy protocols. Compile and review QA metrics for stem cell/cell therapy collections, donor center collections and all therapeutic apheresis procedures.
• Proficient in the following systems; EPIC, SOFT, SOFTDONOR, PolicyStat, Onpoint, MediaLab, CAP website
• Provide education and maintain training records for staff in FACT, AABB, FDA and CAP requirements
• Prepare reports documenting Laboratory QA activities for review by Laboratory Administration and Hospital PI Committees.

Minimum Qualifications

• Bachelor’s Degree in Medical Laboratory Science, Nursing, or related field.
• 5 years experience in related field.
• Educate staff and maintain training records on requirements by FACT, AABB, FDA, and CAP.
• Collaborates with Nurse Supervisor and Charge Nurse to ensure adherence to policies, procedures and protocols
• Documents deviations from procedures and protocols.
• Serves as a resource for staff regarding regulatory requirements and quality activities.
• QLS - Qualification in Laboratory Safety - American Society for Clinical Pathology or
• RN - Licensed Registered Nurse_PA - State of Pennsylvania

Physical Demands

Lift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts.

Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.

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