Senior Clinical Laboratory Scientist

4 weeks ago

Seattle, United States National Marrow Donor Program Full time

POSITION SUMMARY: Please apply online using a laptop or desktop computer. The Senior Clinical Laboratory Scientist role performs laboratory testing procedures and laboratory management in a safe and effective manner resulting in quality cell product collections for optimal patient outcomes. These procedures include but are not limited to, complete blood count (CBC) testing of peripheral blood and apheresis products, and flow cytometry testing (CD34 ) of peripheral blood and apheresis products. This role performs these functions as a member of the interdisciplinary healthcare team and in accordance with established policies, procedures, and regulations. The Senior Clinical Laboratory Scientist performs all duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA), Clinical Laboratory Information Act (CLIA), American Association of Blood Banks (AABB), Foundation for the Accreditation of Cellular Therapy (FACT), and other applicable Federal, State and Local regulations. This position is onsite at our Seattle Collection Center. Check out our video Saving Lives: It's the Best Job Ever ACCOUNTABILITIES: Laboratory Procedures: Performs routine testing of biological samples. Serves as the CAP Technical Supervisor for high complexity testing in the laboratory. Performs routine maintenance and calibration of laboratory instruments and equipment. Performs preparation and prequalification of reagents. Performs routine validation of laboratory instruments and equipment. Maintains cleanliness and order of the laboratory space. Orders and stocks supplies and reagents as needed. Performs all duties as assigned in compliance with NMDP Standard Operating Procedures (SOP) and applicable federal and local regulations. Maintains accurate records and documentation. Participates in SOP, validation report, and other documentation creation. Participates in quality improvement activities. Other duties as assigned. Quality Assurance: Performs root cause analysis and investigation of events identified in the Quality Incident system or through FormsNet, as applicable. Collaborates with Transplant Medical Services, Donor Center staff, and Network members regarding incident recognition, protocol deviations, documentation, follow- up, and other quality assurance issues. Acts as liaison with NMDP Quality in identifying and reporting trends related to quality assurance. Risk Management: Communicates with key NMDP stakeholders when a serious event is identified as a potential risk management concern. Mitigates risk by active participation in problem solving and appropriate interventions during an event as well as effective communication post-event. Consults with Legal and Regulatory, as needed. REQUIRED QUALIFICATIONS: Knowledge of: Medical/scientific knowledge of stem cell donation. Hematology instrumentation. Flow cytometry instrumentation. FDA Biologics, Drug and Tissue regulations (including GMP/GTP), HIPAA, and other applicable regulatory requirements. CLIA requirements for high complexity testing. Ability to: Effectively summarize and communicate laboratory results. Solve complex problems making timely and sound decisions. Exercise independent judgment utilizing appropriate resources. Handle multiple issues with flexibility and appropriate prioritization. Exhibit strong

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