Clinical Laboratory Scientist II

Overview

Exagen is a patient-focused and discovery-driven life sciences company dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases. Our goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis, and monitoring of complex autoimmune and autoimmune-related diseases, including lupus and rheumatoid arthritis. By leveraging our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology, we help get to the real cause of a patient’s symptoms and guide their journey to improved health.

The Clinical Laboratory Scientist is responsible for the high complexity testing and analysis of patient’s samples in the Flow and Immunochemistry departments. Works closely with the Head of Immunology to ensure that all testing complies with all regulatory standards for the clinical laboratory.

The shift for this position will be Tuesday – Saturday, 2:00 PM - 10:30 PM. Shift times may change as needed based on business needs and coverage.

Responsibilities

Note: Other duties may be assigned.

• Demonstrate proficiency, competency, and understanding of fundamental principles of clinical laboratory procedures. • Review test data, quality control, quality assurance, preventive maintenance, proficiency testing, and other operational activities related to laboratory testing procedures. • Conduct quality laboratory testing, including analysis, review, and reporting of Flow and Immunochemistry results, in accordance with approved laboratory procedures. • Perform quality control procedures, interpret clinical values, including critical values and delta checks, and determine when test results are reportable, including review of standard curves, controls, reagents and troubleshooting. • Document quality control results, out-of-range findings, and corrective actions appropriately. • Operate assigned laboratory equipment, which may include Flow Cytometer, Quantalyzer, NOVAView, TECAN-EVO 100, HELMER Ultra-Cell Washer, BIO-TEK ELX50 automated strip washer, Eppendorf centrifuge, and other equipment as required. • Perform and document routine daily, weekly, and monthly maintenance and calibration of laboratory instrumentation. • Create testing batches in the Laboratory Information System prior to testing and identify and resolve pending specimen results in the system. • Assist with investigation and resolution of complaints, problems, discrepancies, critical values, unusual laboratory situations, analytical issues, and system performance concerns; notify lab management as appropriate. • Assist in troubleshooting issues involving the Laboratory Information System, equipment, instruments, and assay performance. • Follow troubleshooting procedures to correct instrument or equipment deficiencies and collaborate with equipment vendors to initiate maintenance or repairs as needed. • Monitor, manage, and maintain sample storage, reagents, and supply inventory for the department. • Perform IFA analysis, Flow Cytometry analysis and ELISA data review. • Perform basic mathematical calculations required for reagent preparation. • Participate in the Quality Assurance program, including identifying, recording, and correcting nonconformances through Corrective or Preventive Action Requests. • Oversee, review, and verify the work of other laboratory personnel as assigned. • Provide training, guidance, and pertinent technical information to Clinical Laboratory Scientists, laboratory technicians, assistants, and support staff. • Collaborate with the Research department, Head of Immunology, and Project Coordinator on assay validation and improvement activities. • Participate in internal and external audits as required. • Observe all laboratory, Exagen, and regulatory agency policies and procedures. • Maintain department safety, including chemical and biological safety, under established safety, infection control, and procedural protocols. • Follow safety procedures and use all required safety devices and personal protective equipment according to protocol. • Work in a professional, cooperative, and courteous manner and communicate effectively with internal personnel. • Assist with interviewing and training employees as needed. • Perform other duties as assigned.