Flow Cytometry Lab Supervisor, 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.

The Flow Cytometry Supervisor is responsible for the daily operations, compliance, and administration of the Flow cytometry department. Works closely with laboratory management to provide technical direction and ensure that all testing complies with all regulatory standards for the clinical laboratory

The shift for this position will be Tuesday - Saturday, 9:00 AM - 5:30 PM. Other shift changes on as needed based on business needs/coverage.

Responsibilities

• Be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor;

• Responsible for providing day-to-day supervision of high complexity test performance by a testing personnel qualified under § 493.1489; and to be onsite to provide direct supervision when high complexity testing is performed by any individuals qualified under § 493.1489(b)(5);

• Responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.

• Ensure that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;

• Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;

• Provide orientation & training to both testing personnel & non-testing laboratory support personnel, evaluating and documenting competency assessments of lab personnel.

• Maintain quality results by performing and or reviewing instrument comparison, alternate proficiency test, and other quality assurance requirements.

• Perform, evaluate, and report all routine flow cytometry and hematology laboratory tests according to established protocols.

• Investigate the complaint, problem, and discrepancy, as needed.

• Assist in advanced troubleshooting issues involving LIS, equipment, instruments, and assay performance.

• Create, revise and implement existing and new Standard Operating Procedures.

• Collaborate with equipment vendors to initiate maintenance or repair of instruments.

• Monitor reagents and supplies inventory for the department.

• Directly responsible for ensuring the teams' adherence to protocols, appropriate management, and distribution of workload ensuring compliance with CLIA and CAP requirements.

• Provides support for all laboratory functions including inventory management, purchasing, and planning.

• Maintain adequate staffing, approves timesheets for payroll, and hires/evaluates/reviews individual's overall performance.

• Comply with Exagen & regulatory agency policies & procedures.

• Maintain overall safety (including chemical & biological) of the department under established safety, infection control & procedure protocols.

• Assist in the Research department activities and the assay validation.

• Participate in internal and external audits as required.

Qualifications

• Bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution

• Have a minimum of 2 years of Flow cytometry and hematology experience and overall 4 years of testing experiences in a CAP/CLIA accredited hospital or clinical laboratory

• A minimum of 1-year supervisor experience

• Current and valid California State Clinical Laboratory Scientist Generalist License (CLS)

• CAP, CLIA, and NYS regulation experience

Salary range: $130,000 - $150,000