Clinical Laboratory Scientist II

Exagen Inc.; Vista (CA); On-site; USD 79,000 - 99,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement savings program

Paid time off

Job summary

Exagen Inc. is seeking a California-licensed CLS/CCS professional to perform high-complexity laboratory testing, including ELISA and IFA analyses, in a patient-focused environment.

You will maintain quality control, run sophisticated instruments, and support assay validation and audits. Qualified candidates have a CA CLS/CCS license or equivalent, a Bachelor's or Associate degree in a lab science, and at least 3 years of lab experience.

Qualifications

• California State CLS or CCS license or equivalent.
• Bachelor's or Associate degree in laboratory science/medical technology.
• Minimum 3 years of high-complexity laboratory testing experience including ELISA.
• Experience performing and interpreting Indirect Immunofluorescence Assay (IFA).
• Strong understanding of laboratory quality standards, regulations, and best practices.

Responsibilities

• Demonstrate proficiency in clinical laboratory procedures.
• Review test data, quality control, QA, and maintenance activities.
• Conduct quality testing and report Flow and Immunochemistry results per procedures.
• Perform QC, interpret values, determine reportability; review curves, controls, reagents, troubleshooting.
• Document QC results, out-of-range findings, and corrective actions.
• Operate laboratory equipment (e.g., Flow Cytometer, NOVAView, TECAN-EVO 100, etc.).
• Perform maintenance and calibration of instruments.
• Create testing batches in LIS and resolve pending results.
• Assist with investigations of complaints and discrepancies; notify lab management.
• Troubleshoot LIS, equipment, and assay performance issues; coordinate maintenance with vendors.
• Monitor sample storage, reagents, and inventory.
• Perform IFA analysis, Flow Cytometry analysis, and ELISA data review.
• Calculate basic reagent preparations.
• Participate in QA program and CAPA processes.
• Oversee and verify work of others; provide training and guidance.
• Collaborate on assay validation with Research and Immunology teams.
• Participate in audits and follow safety and regulatory procedures.
• Maintain safety and professional conduct; assist with interviewing staff.

Skills

ELISA testing

IFA testing

Quality standards

Education

Bachelor's degree in clinical laboratory science or related

Associate degree in laboratory science or medical technology

Tools

Flow Cytometer

NOVAView

TECANA EVO 100

BIO-TEK ELX50

Job description

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 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

• 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.

Qualifications

• A current and valid California State Clinical Laboratory Scientist License (CLS) or Clinical Chemistry Scientist (CCS).
• Bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology from an accredited institution
• Or have earned an associate degree in laboratory science, or medical laboratory technology from an accredited institution
• Minimum 3 years of experience performing high-complexity laboratory testing, including hands-on ELISA testing experience.
• Experience performing and interpretjing Indirect Immunofluorescence Assay (IFA) testing required.
• Strong understanding of laboratory quality standards, regulations, and best practices.

Pay Range: $57-72/hour

Benefits: We offer a competitive benefits package designed to support the health, financial well-being, and work-life balance of our employees, including medical, dental, and vision insurance; Health Care and Dependent Care Flexible Spending Accounts; a 401(k) retirement savings program; 4 weeks paid time off (PTO); paid company holidays; employer-paid life insurance; optional life insurance; and employer-paid short-term and long-term disability insurance.