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National Marrow Donor Program Infectious Disease and International Eligibility Specialist-2100001P in Minneapolis, Minnesota

POSITION SUMMARY:This position is responsible for performing a variety of operational activities to ensure quality and regulatory compliance as it pertains to the manufacturing process of cellular therapy products. This role's main responsibilities include review of infectious disease testing results for domestic and international donor centers/registries. It also includes the review of eligibility paperwork provided by international registries and cord blood banks to ensure completeness and accuracy of the information, and based on the information provided, determine the eligibility of these international donors and cord blood units in accordance with FDA requirements.Project assignments include coordinating the activities of a network of IDM testing laboratories subcontracted to the NMDP as well as assisting with the implementation of new contract laboratories. Other assignments include managing project data using database tools, spreadsheets, and reports, as well as serving as a laboratory liaison for NMDP donor centers, international donor centers/registries, Case Management, and/or cord blood banks. In addition, this position performs a quality assurance review of IDM testing data on donors and cord blood units.Additional responsibilities include, but are not limited to further development and implementation of processes supporting regulatory compliance and quality assurance, the creation and editing of controlled documents, and documentation of or assistance with resolution of occurrences/quality incidents. This position will collaborate with key stakeholders from various departments across the NMDP to support process improvement initiatives and promote an organizational culture of excellence. In addition, this position will participate in special tasks and projects as assigned by the Supervisor of Infectious Disease and International Eligibility.ACCOUNTABILITIES:Determination of International Donor and Cord Blood Eligibility:Reviews all clinical documents provided by international registries, donor centers, and cord blood banks to ensure completeness and accuracy of the information. Communicates with international partners when information is missing or errors are present on the documents and works with these partners to resolve the issues and obtain the needed information.Performs accurate and timely assessment of donor and cord blood eligibility status and completes all necessary paperwork. Performs a verification audit to confirm that all needed information and forms are present and complete. Immediately forwards completed paperwork to the Quality Control Unit for second review.Problem solves issues that might delay or impede timely completion of eligibility determination, which includes closely working with the involved international registry, donor center, or cord blood bank to find a resolution. Communicates any delays to all involved NMDP staff or network partners.Assist as necessary with determination of eligibility for domestic donors and cord blood units.Evaluation and Review of Infectious Disease Testing Results:Monitors and evaluates the integrity of IDM testing information entered into the Be The Match Registry. Manages and analyzes project data using custom design database tools, spreadsheets, reports.Responds to and problem solves laboratory data discrepancies, mislabeled specimens, and other laboratory-related issues.Performs quality assurance review and editing of IDM testing data in systems and forms for donors and cord blood units.Serves as a laboratory liaison to NDMP Donor Centers, International Donor Centers/Registries, Case Management, and Cord Blood Banks.Process Development and Support:Collaborates with subject matter experts across multiple project teams to identify process improvements needs related to infectious disease testing and/or international donor or cord blood activity.Makes recommendations for the creation and/or modification of processes to ensure NMDP remains compliant with regula

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