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The Northwest Lipid Metabolism and Diabetes Research Laboratories (NWRL) is part of the Division of Metabolism, Endocrinology and Nutrition. The NWRL is a preeminent laboratory that has a major reputation nationally and internationally for its research on Lipoprotein(a) and the Lipid Reference Method Laboratory under the Center for Disease Control and Prevention (CDC), as well as with the World Health Organization (WHO) Laboratory for apoA1, apoB, and Lp(a) standardization. The integration of the research and standardization activities with excellent analytical capabilities has provided the strong infrastructure to enable the NWLR to serve as the Central Biochemistry Laboratory for a large variety of multi-site, NIH-supported, clinical trials.
NWRL currently has an outstanding opportunity for a Laboratory Technical Manager. The purpose of this position is to oversee the technical research day-to-day operations of the Northwest Lipid Research Laboratories which supports a large variety of multi-site, NIH-supported, clinical trials and provides national and international reference research and reference method standardization for lipids, apoA1, apoB and Lp(a) standardization. This position will provide strategic direction in the management of NWRL quality assurance/quality control (QA/QC) programs to ensure a high level of quality in support of the policies, goals, and objectives of the laboratory. The NWRL Quality Assurance and Quality Control processes assure the consistency, accuracy, and reliability of performing analyses for many large scale, multi-site, clinical trials and scientific investigations.
This position will have an active role in the strategic direction of research through direct responsibilities for monitoring and improving pre-analytical, analytical and post-analytical laboratory activities to ensure that NWRL results are accurate and consistent. This position will be responsible for the technical review of laboratory proficiency testing with the College of American Pathologists (CAP), as well as the inter-laboratory comparison testing programs (e.g. International Auto-antibodies Standardization Program, National Glycohemoglobin Standardization Program, and Lipid Standardization Program). The Laboratory Technical Manager will review with the Director all laboratory proficiency testing results, complete investigations to evaluate any issues, and develop and document any needed corrective actions. The Laboratory Technical Manager will provide active surveillance of all NWRL quality control results, including long term consistency monitoring, and will perform routine audits in each area of the laboratory to ensure compliance with established procedures.
Research and Management
Implement and update the laboratory Quality Management program in support of strategic planning surrounding the overall research laboratory activities performed by the NWRL, as outlined in the NWRL Quality Assurance and Quality Control protocols.
Monitor and review all laboratory operations to provide the most efficient and highest quality results and services. Includes analysis of data, preparation of reports, and making recommendations for improving laboratory operations. Responsible for daily audits of Laboratory Information System (LIMS) reports for quality assurance, controls such as critical alerts, daily blind split data, tests close to or exceeding study specific turnaround times, shipment notifications and pending data lists. Perform weekly audit of quality control data for performance, noting trends or deviations and documenting actions and resolutions. Perform monthly audit of critical records for quality assurance, documenting review and data collection for performance management purposes. Communicate with appropriate staff members when corrective actions are required, document and follow-up to ensure resolution. Report any unresolved quality control issues to the Director. Meet with the Director and laboratory technical staff to discuss contents of audit reports and take actions per NWRL quality control protocols.
Plan and make improvements to the NWRL's QA/QC program based on laboratory best practices. Maintain adequate records of all daily, weekly, and monthly QA/QC variables and corrective actions.
Review internal and external survey results for accuracy of analysis and technical proficiencies of personnel. Review and verify manually recorded survey data prior to submission to accrediting agencies. Participate in accreditation inspections by the College of American Pathologists and other regulatory inspections or client visits as requested by Director.
Review, assess, and approve changes to critical laboratory documents such as Standard Operating Procedures (SOPs), associated safety protocols, and documentation to ensure improvement in laboratory practices and quality. Develop and write new laboratory SOPs as required. Ensure all laboratory SOP changes are communicated and ensure proper implementation with appropriate NWRL technical personnel.
Oversee and approve validation of new assays prior to analyzing samples for research clientele. Review and approve all internal NWRL Study Protocols. Review annual client survey, error rates, and incident reports. Review outside investigator requested comparisons. Investigate any client complaint to identify root cause(s) and provide response.
Meet with the Director and Research Study Manager on a regular basis and undertake other research/management projects and duties as requested by Director.
Supervise NWRL research technical personnel. This includes all aspects of personnel management such as project supervision, hiring, training, and evaluations.
Responsible for training technical personnel on NWRL standard operating procedures. Ensure technical personnel are equipped to follow laboratory best practices. Actively monitor training of all NWR technical staff when being trained by other senior technical personnel.
Conduct annual employee competency and performance reviews of the NWRL technical personnel based on job descriptions to determine competency, knowledge, and contribution of technical personnel towards NWRL goals and objectives.
Communicate regularly with all NWRL technical personnel, both individually and as a group, to ensure consistent implementation of laboratory practices, policies, and standard operating procedures.
Oversee the use and inventory of laboratory chemicals and supplies. Assist in the review and evaluation of laboratory instrumentation and other duties as assigned.
Work with the Finance Manager of the Recharge Center to establish appropriate rates for new testing required by research clientele.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.