Clinical Lab Scientist Specialist

University of California, San Francisco • San Francisco, CA

5d • Hybrid

About The Position

Responsible for administering and maintaining Quality Assurance Programs, including monitoring Quality Control and Proficiency Test Surveys. The position performs internal audits; assists with external and internal inspections and regulatory compliance; participates in quality improvement initiatives; and leads Safety Program initiatives and tasks. Other duties may be assigned.

The schedule is Monday through Friday, 8:30 AM to 5:00 PM, and may change to reflect laboratory needs. The role is hybrid, combining onsite and at-home work as assigned, with the business office at China Basin. Flexibility to orient and work at all UCSF Health locations as needed is required.

The role manages Quality Control and Proficiency Test Survey programs, leads safety-related activities, supports regulatory compliance and laboratory licensure and accreditation, conducts internal audits and assists with inspections, and contributes to process updates and quality initiatives. Duties also include LIS calculation verification and related data and documentation work.

Requirements

• College graduate with a BS or BA in a related science.
• Valid California Clinical Laboratory Scientist license.
• Three years of recent experience in a clinical laboratory.
• Knowledge of Quality Control, Proficiency Testing, and laboratory inspections.
• Experience with Quality Assurance practices and procedures.
• Flexibility to orient and work at all UCSF Health locations as needed.

Nice To Haves

• CLS Generalist qualification.
• Knowledge and experience in Transfusion Medicine.
• Experience with current laboratory automated equipment.
• Experience in a high-volume hospital clinical laboratory setting.

Responsibilities

• Manage the Quality Control Program by analyzing results for imprecision, shifts, or trends; requesting section supervisor responses; generating and reviewing monthly statistical summary reports and Levey-Jennings charts; addressing out-of-control situations; documenting control range adjustments; distributing updated action range charts; coordinating reviews of new control products; ensuring QC data collection; calculating new action limits; and entering new control material lots into the laboratory computer.
• Manage the Proficiency Test Survey Program by ordering CAP surveys, accessioning and distributing tests, contacting CAP about survey problems, monitoring survey progress, organizing results for Medical Director or designee review, tracking due dates and completion, processing and distributing evaluations, reviewing results for failures, biases, and outliers, and following up with sections to ensure responses and timely submissions.
• Lead and serve as a contact for internal safety rounds, hospital inspections, and external safety inspections; adhere to safety and infection control policies; and report inspection and round results at Clinlab Safety Meetings.
• Serve as a contact for regulatory compliance and quality inquiries and searches; assist in maintaining current laboratory licenses and accreditations, required databases, forms and signatures; track renewals and post current licenses.
• Conduct internal audits of operational processes, CAP self-inspections, mock inspections, records, and documents.
• Assist with external inspections, including logistics, document gathering, interviewees, and close-out activities; assist with follow-up and documentation after self-inspections, external inspections, and internal audits.
• Assist in establishing and updating work methods, processes, and procedures.
• Assist with spreadsheet creation and data entry, and participate in identified clinical laboratory quality improvement initiatives by collecting and organizing data, findings, and results.
• Perform LIS calculation verification and other duties as assigned.

What This Job Offers

• Job Type: Full-time