Clinical Laboratory Scientist II

Exagen Inc. • Vista, CA

3d • $57 - $72

About The Position

Exagen is a patient-focused, discovery-driven life sciences company focused on improving care for people with chronic autoimmune diseases. The Clinical Laboratory Scientist performs high-complexity testing and analysis of patient samples in the Flow and Immunochemistry departments and works closely with the Head of Immunology to ensure testing complies with clinical laboratory regulatory standards. The shift is Tuesday through Saturday, 2:00 PM to 10:30 PM; shift times may change to meet business needs and coverage.

Requirements

• Current, valid California State Clinical Laboratory Scientist (CLS) or Clinical Chemistry Scientist (CCS) license.
• Bachelor's degree in chemical, physical, biological, or clinical laboratory science, or medical technology, from an accredited institution; alternatively, an associate degree in laboratory science or medical laboratory technology from an accredited institution.
• At least 3 years of experience performing high-complexity laboratory testing, including hands-on ELISA testing.
• Experience performing and interpreting Indirect Immunofluorescence Assay (IFA) testing.
• Strong understanding of laboratory quality standards, regulations, and best practices.

Responsibilities

• Demonstrate proficiency, competency, and understanding of fundamental clinical laboratory procedures.
• Review test data, quality control, quality assurance, preventive maintenance, proficiency testing, and other operational activities related to laboratory testing.
• Conduct quality laboratory testing, including analysis, review, and reporting of Flow and Immunochemistry results in accordance with approved procedures.
• Perform quality control procedures; interpret clinical values, including critical values and delta checks; determine whether results are reportable; and review standard curves, controls, and reagents while troubleshooting.
• Document quality control results, out-of-range findings, and corrective actions.
• Operate assigned laboratory equipment, including equipment such as flow cytometers, Quantalyzer, NOVAView, TECAN-EVO 100, HELMER Ultra-Cell Washer, BIO-TEK ELX50 automated strip washer, and Eppendorf centrifuge.
• Perform and document routine daily, weekly, and monthly maintenance and calibration of laboratory instruments.
• Create testing batches in the Laboratory Information System before testing and identify and resolve pending specimen results in the system.
• Assist with investigating and resolving complaints, problems, discrepancies, critical values, unusual laboratory situations, analytical issues, and system performance concerns; notify lab management as appropriate.
• Assist with troubleshooting the Laboratory Information System, equipment, instruments, and assay performance.
• Follow troubleshooting procedures to correct instrument or equipment deficiencies and coordinate with vendors on maintenance or repairs as needed.
• Monitor and maintain sample storage, reagents, and departmental supply inventory.
• Perform IFA and Flow Cytometry analyses and review ELISA data.
• 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 other laboratory personnel's work as assigned.
• Provide training, guidance, and 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.
• Participate in internal and external audits as required.
• Follow laboratory, company, and regulatory agency policies and procedures.
• Maintain departmental chemical and biological safety under established safety, infection-control, and procedural protocols.
• Follow safety procedures and use required safety devices and personal protective equipment.
• Work professionally and cooperatively, and communicate effectively with internal personnel.
• Assist with interviewing and training employees as needed.
• Perform other duties as assigned.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Health Care and Dependent Care Flexible Spending Accounts
• 401(k) retirement savings program
• Four weeks of paid time off
• Paid company holidays
• Employer-paid life insurance
• Optional life insurance
• Employer-paid short-term disability insurance
• Employer-paid long-term disability insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level