Clinical Laboratory Scientist (CLS) – Generalist or Specialist

About the Role
The California Department of Public Health (CDPH), Center for Laboratory Sciences, is staffing Full-Time Equivalent (FTE) Contract Clinical Laboratory Scientists (CLS) within the Laboratory Field Services (LFS) Branch. California Clinical Laboratory Law requires that anyone working in a clinical chemistry laboratory hold a CLS license in clinical chemistry.

LFS is required by California law to inspect licensed clinical laboratories at least every two years, a process governed by the federal Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Scientists hired under this contract play a critical role in regulatory compliance, quality testing, result interpretation, emergency response, research advancement, patient safety, and collaboration with healthcare professionals across the state.

Key Responsibilities
Regulatory Inspection & Compliance
Conduct CLIA-based biennial inspections of California-licensed clinical laboratories on behalf of the LFS Branch.
Evaluate laboratory operations, testing personnel competency, quality control, quality assurance, and proficiency testing programs for compliance with California Clinical Laboratory Law and CLIA standards.
Document inspection findings, identify deficiencies, and prepare formal reports outlining corrective actions and follow-up requirements.
Review and validate laboratory responses to deficiencies; verify implementation of corrective action plans.

Field Consultation & Technical Guidance
Provide expert field consultation to clinical and public health laboratories on regulatory requirements, methodology, validation, instrumentation, and best practices.
Interpret laboratory test results and advise laboratory directors, supervisors, and testing personnel on technical and operational issues.
Support emergency response activities and outbreak investigations requiring rapid laboratory consultation.

Laboratory Operations & Quality
Apply expertise as a staff specialist in technical areas of clinical and public health laboratory sciences (e.g., chemistry, hematology, microbiology, immunology, molecular diagnostics, toxicology, or related specialties).
Support supervision of professional laboratory staff and, where applicable, serve in lab director or designee capacities consistent with CLS scope of practice.
Contribute to development, review, and updating of LFS inspection tools, checklists, and standard operating procedures.

Collaboration & Reporting
Coordinate with CDPH program staff, the California Department of General Services, and federal partners as needed.
Maintain accurate inspection records, case files, and regulatory documentation in accordance with state retention policies.
Participate in continuing education, calibration sessions, and inspector training to ensure consistent application of standards statewide.

Minimum Qualifications
Active and unrestricted California Clinical Laboratory Scientist license – Generalist or Specialist – issued by CDPH Laboratory Field Services. A CLS license in clinical chemistry is required for any assignment in a clinical chemistry laboratory.
At least three (3) consecutive years of experience – within the past five (5) years – in one or more of the following: field consultation in clinical or public health laboratories; supervision of professional laboratory staff or service as a laboratory director; or work as a staff specialist in technical areas of clinical or public health laboratory sciences.
Demonstrated working knowledge of CLIA regulations, California Clinical Laboratory Law (Business and Professions Code, Division 2, Chapter 3), and applicable Title 17 California Code of Regulations requirements.
Eligibility to work in the United States and ability to pass any background, security, or fingerprinting checks required by CDPH.

Preferred Qualifications
Prior CLIA surveyor / inspector experience with a state survey agency, CMS, or accrediting organization (e.g., CAP, COLA, The Joint Commission).
Specialty CLS licensure in clinical chemistry, microbiology, hematology, immunohematology, cytogenetics, or molecular biology.
Experience presenting technical findings to laboratory leadership and writing formal inspection or audit reports.
Bachelor's or higher degree in clinical laboratory science, medical technology, or a closely related biological / chemical science.

Core Competencies & Skills
Strong analytical and problem-solving skills, with attention to regulatory detail.
Excellent written and verbal communication; ability to deliver constructive feedback to laboratory personnel.
Sound professional judgment, integrity, and impartiality when evaluating regulated entities.
Proficiency with Microsoft Office and laboratory information systems; ability to use electronic inspection tools.
Ability to manage a travel schedule, prioritize multiple inspections, and meet documentation deadlines.