Clinical Lab Scientist Specialist
About The Position
The Clinical Lab Scientist Specialist is responsible for administering and maintaining laboratory Quality Assurance Programs, including monitoring Quality Control and Proficiency Test Survey programs. The role 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 position manages QC and proficiency testing programs, including reviewing quality data and survey results, coordinating responses to issues, maintaining records and schedules, and supporting compliance with laboratory standards and accreditation requirements. It also serves as a contact for regulatory, quality, and safety matters and supports audits, inspections, process updates, data collection, and LIS calculation verification. Workdays and hours may change based on laboratory needs. The stated schedule is Monday through Friday, 8:30 AM to 5:00 PM. Work is hybrid, split between on-site and at-home work as assigned. The business office is at China Basin, and the employee must be flexible to orient and work at all UCSF Health locations as needed.
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 QC, proficiency testing, and laboratory inspections.
- Experience with Quality Assurance practices and procedures.
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
- Administer and maintain Quality Assurance Programs, including monitoring Quality Control and Proficiency Test Survey activities.
- Manage the QC Program by analyzing performance for imprecision, shifts, and trends; reviewing and generating statistical reports and Levey-Jennings charts; addressing out-of-control situations; maintaining control ranges and logs; coordinating review of new control products; and entering new control material lots and data into the laboratory computer.
- Manage the Proficiency Test Survey Program by ordering CAP surveys, accessioning and distributing tests, communicating survey problems to CAP, tracking survey progress and deadlines, organizing results for Medical Director or designee review, processing and distributing evaluations, reviewing results for failures, biases, and outliers, and following up with section supervisors and site staff.
- Lead and serve as the contact for internal safety rounds, hospital inspections, and external safety inspections; attend and report on these activities at Clinical Laboratory Safety Meetings.
- Adhere to safety and infection control policies and procedures.
- Serve as a contact for regulatory compliance and quality inquiries and searches.
- Assist with maintaining current clinical laboratory licenses and accreditations, including required databases, forms, signatures, renewal tracking, and posting current licenses.
- Perform internal audits of operational processes, CAP self-inspections, mock inspections, records, and documents.
- Assist with external inspection logistics, document gathering, interviewees, and close-out activities; support follow-up and documentation after self-inspections, external inspections, and internal audits.
- Assist in establishing and updating work methods, processes, and procedures.
- Create spreadsheets and enter data as needed.
- Assist with or participate in quality initiatives for clinical laboratory improvements, including collecting and organizing data, findings, and results.
- Verify LIS calculations.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
