To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
This position is a member of the Stem Cell Transplant Program with accountability for programmatic quality oversight as directed, inclusive of the Apheresis unit, to ensure compliance with all applicable regulatory agencies (FDA, FACT, AABB, etc.). The incumbent is responsible for coordinating all quality activities in Apheresis to support the Adult and Pediatric Hematopoietic Stem Cell Transplant and Immune Effector Cell Therapy Programs, as well as all clinical trials involving investigational cell therapy products. Responsible for all quality aspects in cellular products manufacturing (collection, labeling, storage, transporting, release/dispensing) to support the Stem Cell Transplant Program and clinical trials (INDs) conducted at YNHH. It also includes analysis of quality and performance improvement including coordination and collection of data, analysis and trending of required regulatory indicators (internal and external), process measures and clinical outcomes measures. This position interacts closely with the unit manager and staff in these areas to assure compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards and other quality measures identified by program leadership. Education to promote regulatory readiness and ongoing accreditation compliance.
- 1. Develops, revises and maintains the quality management plan for the Apheresis unit, integrating with the quality management plans for the other Stem Cell Transplant program components.
- 2. Reviews and is knowledgeable about all applicable regulations of the FDA, FACT, AABB, CAP, CLIA, TJC, State of Connecticut and other relevant agencies. Monitors all new regulations and ensures that processes and procedures comply with requirements.
- 3. Ensures that the Apheresis unit is prepared for regulatory site visits and other external audits. Maintains associated applications, checklists, and other documents related to regulatory/ accreditation compliance.
- 4. Serves as a resource and consultant for quality activities to the clinical program and marrow collections staff as needed.
- 5. Facilitates the coordination of multidisciplinary efforts in regard to regulatory readiness. Provides leadership in meeting goals and objectives.
- 6. Prepares periodic reports regarding quality activities, and presents as needed on the status of the quality management system.
- 7. Conducts audits to ensure the quality management system is operating effectively; analyzes collected data , and coordinates multidisciplinary corrective action plans and quality improvement activities.
- 8. Reviews Event and Variance/Deviation reports from Apheresis; makes recommendations for corrective and preventive actions and tracks and trends events. Reports Biological Product Deviations to FDA as required.
- 9. Maintains the Document Control system for Apheresis.
- 10. Reviews all SOPs, policies, change controls, corrective and preventative action plans, and engraftment/outcome data.
- 11. Reviews and approves training materials and competency assessments to ensure that all personnel have been trained and are competent in any new or revised procedure that apply to their duties and training / competency is documented.
- 12. Qualifies and approves suppliers of critical equipment, supplies and services.
- 13. Creates, reviews and implements validation plans to ensure compliance with all applicable regulations.
- 14. In conjunction with Medical Director and Facility Director communicates with study principal investigators, IRB & FDA.
- 15. As necessary, facilitates and coordinates projects to improve processes in Apheresis. Interacts with directors, managers, and staff in relation to projects.
- 16. Keeps abreast of recent developments in the Apheresis and Cellular Therapy field.
- 17. Performs other job duties as required
Bachelor's degree in science, nursing, or other healthcare specialty preferred but not required.
At least 3 years experience in apheresis, stem cell transplantation, clinical laboratory, and/or regulatory compliance/quality assurance preferred.
RN, Clinical Laboratory Specialist, or Medical Technologist (ASCP) preferred.
Excellent organizational, verbal and written communication skills, as well as presentation skills required. Must be proficient in the use of Microsoft Word , Powerpoint and Excel.
Stem cell, apheresis, and/or quality experience preferred. Excellent customer service skills, attention to detail, and ability to manage multiple priorities required.