Clinical Laboratory Scientist II (CLS)

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.

About the Opportunity:

The Immunochemistry CLS II (Clinical Laboratory Scientist) is responsible for the daily operations and compliance of the Immunochemistry department. Works closely with the Associate Director of Immunochemistry to ensure that all testing complies with all regulatory standards for the clinical laboratory.

The shift for this position will be Tuesday - Saturday. Other shift changes on as needed based on business needs/coverage.

Responsibilities

Note: Other duties may be assigned.

• Demonstrates proficiency, competency & understanding of fundamental principles of clinical laboratory procedures.
• Perform Quality Control (QC) procedures and interpretation of clinical values, including critical values and delta checks. Knows when test results are reportable and what to do in case of Quality Control failure.
• Perform and log routine daily, weekly, and monthly maintenance and calibration of laboratory instrumentation according to protocols. Strictly adheres to written procedures.
• Maintain quality results by performing and or reviewing instrument comparison, alternate proficiency tests, and other quality assurance requirements.
• Perform, evaluate, and report all routine Immunochemistry laboratory tests according to established protocols.
• Help with the investigation of complaints, problems, critical values,  and discrepancies, as needed.
• Identifies & helps resolve unusual laboratory situations & notifies the Director of immunochemistry.
• Participate in the Quality Assurance program included by not limited to :
• Identify, record and correct nonconformance's on Corrective or Preventive Action Requests
• Oversee, review, and verify the work of other lab personnel.
• Maintain a detailed account of results with great attention to accuracy
• Review test data, quality control, quality assurance, preventive maintenance, proficiency testing, and other operations activities related to laboratory testing procedures.
• Ability to assist in troubleshooting issues involving LIS, equipment, instruments, and assay performance.
• Collaborates with equipment vendors to initiate maintenance or repair of instruments.
• Monitor reagents and supplies inventory for the department.
• Provides training, guidance & pertinent technical information to other Clinical Laboratory Scientists, Laboratory technicians, Assistants, and support staff.
• As defined by established standards, works in a professional, cooperative & courteous manner.
• Observes all laboratory, Exagen & regulatory agency policies & procedures.
• Maintains overall safety (including chemical & biological) of the department under established safety, infection control & procedure protocols.
• Collaborates with Research and Development department and Technical Supervisor of Immunochemistry and Project Coordinator for assay validation and improvement.
• Participates in internal and external audits as required.
• Other responsibilities include assisting with interviewing, and training employees as needed.

Qualifications

Minimum Qualifications:

• A current and valid California State Clinical Laboratory Scientist License (CLS) or Clinical Chemistry Scientist (CCS)
• Bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution
• three to five years of Laboratory experience
• Experience with performing and reporting ELISA assays
• Knowledge of computer skills, quality control, and instrument maintenance
• Intermediate Microsoft Windows experience, proficient in Excel and Word

Preferred Qualifications:

• Ability to work a flexible schedule and overtime hours as needed
• Knowledge of accepted clinical laboratory practice and procedures including handling of potentially infectious material and familiarity with California law relating to the practice of medical technology
• Two to three years of automation experience and reporting of ELISA assays
• Two to three years experience Immunofluorescence ANA slide interpretation
• Experience training and performing Competency assessments
• Strong communication skills, both written and verbal
• Analytical problem-solving skills, proficiency in performing detailed tasks thoroughly and completely, and the ability to follow complicated instructions with accuracy.
• Good organizational skills
• The ability to read, write, speak, understand, and communicate satisfactorily in English, in person, and on the telephone
• Strong knowledge of lab equipment, lab procedures, and quality control

Pay range: $56 - $65/hr