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

Jefferson Health; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Thomas Jefferson University Hospitals, Inc. is seeking a dedicated Quality Assurance Coordinator (Full Time) for the Transplant and Cellular Therapy Lab in Philadelphia, PA.

This role maintains the Quality Management system in compliance with FDA regulations and standards from FACT, AABB and CAP, directing QA/improvement actions for Transfusion Medicine. You will develop and maintain department policies and procedures, implement and document QA activities, and coordinate education and training

Qualifications

• Minimum 5 years' experience in a related quality or regulatory field.
• Educates staff and maintains training records on FACT, AABB, FDA, and CAP requirements.
• Collaborates with Nursing leadership to ensure policy adherence.
• Documents deviations from procedures and protocols.
• Serves as a regulatory resource for staff.

Responsibilities

• Coordinate Cellular Therapy, Therapeutic Apheresis and Blood Donor Center QA programs.
• Maintain Policy and Procedure Manual for cell therapy partner requirements.
• Ensure CAP, Joint Commission, State, FACT, AABB and other regulatory standards compliance.
• Compile and review QA metrics for stem cell/cell therapy collections and therapeutic apheresis.
• Provide education and maintain training records for staff on regulatory requirements.

Skills

Quality Assurance

Regulatory compliance

Training & education

Documentation

Communication

Education

Bachelor’s Degree in Medical Laboratory Science, Nursing, or related field

Tools

EPIC

SOFT

SOFTDONOR

PolicyStat

Onpoint

MediaLab

CAP website

Job description

Quality Assurance Coordinator (FT) - Transplant and Cellular Therapy Lab### Quality Assurance Coordinator (FT) - Transplant and Cellular Therapy LabApply: Philadelphia, PA: Full time: Posted Today: REQ-0035173**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 Description****Summary** 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. Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.**Work Shift**Workday Day (United States of America)**Worker Sub Type**Regular**Employee Entity**Thomas Jefferson University Hospitals, Inc.**Primary Location Address**1025 Walnut Street, Philadelphia, Pennsylvania, United States of America