Overview
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.
Serving as Laboratory Regulatory and Compliance Coordinator for YNHHS Blood Banks, this position reports to the Director of Laboratory Quality and is responsible for all elements of the Transfusion Medicine quality management program including the performance of audits to ensure the quality management plan is operating effectively and developing and preparing reports to management on the status of the quality management program. The incumbent has responsibility for inspection/site visit preparation, coordination of site visit logistics and response, as well as for coordinating report-out to management of major regulatory changes and issues, and mock or real survey results. Works independently with medical staff, laboratory, and other departments to plan, organize, facilitate, implement and measure efforts to improve process efficiencies, maintain regulatory compliance and improve overall patient safety and quality for Transfusion Medicine services.
EEO/AA/Disability/Veteran
Responsibilities
- 1. Designs, implements, and manages the Quality Management Program for Transfusion Medicine in accordance with AABB, CPH, CAP, FDA, NYSDOH, RIDOH, JC, and other accrediting agencies including monitoring of quality metrics.
- 2. Reviews and is knowledgeable about all applicable regulations of the Food and Drug Administration (FDA), Association for the Advancement of Blood & Biotherapies (AABB), College of American Pathologists (CAP), Clinical Laboratory Improvement Amendment (CLIA), The Joint Commission (JC), State of Connecticut (CPH), State of New York (NYSDOH), State of Rhode Island (RIDOH), and other relevant agencies. Monitors all new regulations and ensures that processes and procedures comply with requirements.
- 3. Reviews and approves training materials and competency assessments. Ensures 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 at all YNHHS locations.
- 4. Facilitates the coordination of multidisciplinary efforts in regard to regulatory readiness (e.g. self-assessment, measurement of success data, corrective action plans). Provides leadership in meeting goals and objectives.
- 5. Reviews plans for validation of computer systems to ensure compliance with all applicable regulations.
- 6. Assists with processing Market Withdrawals, Recalls, and Look Back reports from blood suppliers. Investigates reports of suspected transfusion transmitted diseases and reports the results of the investigation to the Medical Director. Assists with root cause analysis and other preventive management strategies.
- 7. Participate in the investigation and documentation of Laboratory Safety Events and Variance reports from Transfusion Medicine; makes recommendations for corrective and preventive actions and tracks and trends events. Reports Biological Product Deviations to FDA as required.
- 8. Prepares periodic reports regarding quality activities and presents to management at least quarterly on the status of the quality management system.
- 9. Ensure that procedures are appropriate and common/standardized for laboratories in which this practice is indicated
- 10. Serve as the content expert and resource for all modules within MediaLab
- 11. Working with the Director of Laboratory Quality, actively participates in departmental meetings and initiatives
- 12. Assist in the coordination of the Proficiency Testing program and the completion of any licensure/certification applications
- 13. Keeps abreast of recent developments in the Transfusion Medicine field. Participates in professional development programs, quarterly variance conferences, transfusion committee meetings, and others as deemed relevant.
- 14. Provides support for special projects, assignments, or other administrative duties as needed
Qualifications
EDUCATION Bachelors Degree in Medical Laboratory Science or a Biological Science required; Masters Degree preferred. EXPERIENCE Three (3) to five (5) years experience in Blood Banking. Experience in a cGMP environment or similar regulatory experience desirable. LICENSURE Six Sigma Green Belt or other quality certification preferred. SPECIAL SKILLS Excellent organizational, verbal and written communication skills, as well as presentation skills required. Must be
able to collaborate effectively with all levels of management. Must be proficient in the use of Microsoft Word, Powerpoint and Excel.
YNHHS Requisition ID
138477
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Yale New Haven Health
Jan 07, 2025