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

Jefferson Health; United States; Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Retirement plans

Tuition assistance

Résumé du poste

Jefferson Health is seeking a Quality Assurance leader for the Transfusion Medicine department in the United States. The role directs QA/Improvement actions and maintains the QA program to ensure compliance with FDA, FACT, AABB and CAP standards.

You will develop policies, train staff, and report QA metrics to hospital leadership, ensuring alignment with regulatory agencies and departmental procedures. This role requires collaboration with nursing leadership and cross-functional teams.

Qualifications

• Bachelor’s degree in medical field required and licensure where applicable.
• 5+ years of experience in quality assurance or regulatory compliance.
• Experience educating staff on FACT, AABB, FDA, CAP requirements; collaborative mindset.

Responsabilités

• Maintain Quality Management system per FDA, FACT, AABB, CAP standards.
• Direct QA/Improvement actions for Transfusion Medicine.
• Develop and update department policies/procedures for regulatory alignment.
• Develop, implement, and document QA activities to improve lab QA program.
• Compile and review QA metrics for stem cell/cell therapy collections and related procedures.
• Provide training and maintain records for staff on regulatory requirements.

Connaissances

Quality Assurance

Regulatory Compliance

Training & Education

Staff Collaboration

Formation

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

Outils

EPIC

SOFT

SOFTDONOR

PolicyStat

Onpoint

MediaLab

CAP website

Description du poste

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

Company Overview

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Equal Opportunity Statement

Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

Benefits

• medical (including prescription)
• supplemental insurance
• dental
• vision
• life and AD&D insurance
• short- and long-term disability
• flexible spending accounts
• retirement plans
• tuition assistance
• 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.

For more benefits information.

Culture and Development

In keeping with Jefferson's Mission, We Improve Lives, it is our goal to recruit, retain, develop and reward highly-qualified employees. If you are enthusiastic, caring and dedicated to service excellence, we invite you to consider joining Jefferson. Jefferson encourages its employees to expand their knowledge and develop their careers through growth opportunities and continuing education. With a long standing history, Jefferson has been advancing the medical field from the heart of Center City Philadelphia for nearly 200 years. Our Mission, We Improve Lives, expands to every corner of the organization. From our weekly farmer’s market, to our new Jefferson Accelerator Zone for innovation, our employees’ passion for the community is evident by the daily gestures towards our patients, students and each other.