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.
Performs routine testing of biological samples
Serves as the CAP Technical Supervisor for high complexity flow cytometry 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 Be The Match 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
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, followup, and other quality assurance issues.
Acts as liaison with NMDP Quality in identifying and reporting trends related to quality assurance.
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: (Minimum qualifications needed for this position including education, experience, certification, knowledge and/or physical requirements) Knowledge of:
Medical/scientific knowledge of stem cell donation
Flow cytometry instrumentation
FDA Biologics, Drug and Tissue regulations (including GMP/GTP), HIPAA, and other applicable regulatory requirements.
CLIA requirements for high complexity testing
Effectively summarize and communicate laboratory results
Solve complex problems making timely and sound decisions