Clinical Laboratory Scientist (CLS)
Location: Richmond, CA / Los Angeles, CA
Contract Duration: 36 Months
Travel: Throughout California and potentially out of state
Work Setting: Laboratory offices and onsite clinical laboratory inspection locations
Position Overview
We are seeking experienced and currently licensed Clinical Laboratory Scientists (CLS) to support a laboratory regulatory oversight and compliance program.
This specialized position combines clinical laboratory science expertise with regulatory compliance, laboratory inspections, quality assurance, investigations, and technical consultation.
The Clinical Laboratory Scientist will work under the general direction of a senior examiner and support the oversight of licensed clinical laboratories and physician office laboratories. The role involves evaluating laboratory operations for compliance with applicable California and federal regulations, including Clinical Laboratory Improvement Amendments (CLIA) requirements.
Mandatory Qualifications
California CLS License
Must possess an active California Clinical Laboratory Scientist (CLS) license.
Generalist or Specialist licenses are acceptable.
Education
Bachelor's degree or higher from an accredited college or university with a major in an appropriate scientific field.
Candidates should be prepared to provide:
Degree
Major
Institution
Graduation year
Relevant Experience
Minimum of 3 years of relevant professional experience in one or more of the following areas:
Field consultation in clinical laboratories.
Field consultation in public health laboratories.
Supervision of professional laboratory staff.
Laboratory Director experience.
Staff specialist experience in technical areas of clinical laboratory sciences.
Staff specialist experience in technical areas of public health laboratory sciences.
Important: General bench CLS experience alone may not satisfy the experience requirement. Candidates must demonstrate relevant experience in at least one of the areas listed above.
Regulatory Knowledge
Working knowledge of clinical laboratory procedures, policies, and practices.
Understanding of applicable California and federal laboratory regulations.
Knowledge of CLIA requirements and laboratory compliance standards.
Ability to interpret and apply regulatory requirements during laboratory inspections and investigations.
Key Responsibilities
Conduct onsite inspections of clinical laboratories and physician office laboratories.
Evaluate laboratory operations for compliance with applicable state and federal regulations.
Conduct complaint investigations and follow-up inspections to verify correction of deficiencies.
Review laboratory survey and inspection reports.
Interpret applicable state and federal laboratory laws, regulations, policies, and procedures.
Consult with field surveyors regarding laboratory regulatory and compliance issues.
Coordinate laboratory inspection schedules and related activities.
Serve as a subject matter expert regarding clinical laboratory regulations and compliance requirements.
Communicate inspection findings during exit interviews.
Prepare formal deficiency reports and review laboratory corrective action plans.
Maintain and update regulatory and compliance information in applicable state and federal databases.
Provide technical assistance to laboratories and respond to inquiries from laboratories, the public, and other stakeholders.
Participate in legal or administrative proceedings related to laboratory sanctions and prepare supporting enforcement documentation.
Attend required training sessions and prepare technical, regulatory, and compliance reports.
Assist in updating procedures, work instructions, and Standard Operating Procedures (SOPs).
Perform laboratory quality assurance and quality control (QA/QC) activities.
Prepare and upload reports for dissemination of laboratory data and test results.
Verify specimen adequacy and perform complex laboratory analyses when required.
Validate test results by correlating findings with appropriate testing parameters.
Maintain complete, accurate, organized, and defensible laboratory and regulatory records.
Prepare accurate data packages, inspection documentation, and technical reports.
Assist supervisors with technical laboratory consultations and regulatory assessments.
Develop, review, and maintain laboratory SOPs and technical procedures.
Present research findings or technical information at scientific meetings when required.
Protect confidential information, laboratory data, and organizational assets in accordance with applicable policies, regulations, and laws.
Required Skills
Clinical laboratory science expertise.
Laboratory inspection and regulatory compliance experience.
Knowledge of CLIA and applicable laboratory regulations.
Strong understanding of laboratory QA/QC practices.
Experience evaluating laboratory procedures, documentation, and compliance.
Strong analytical and investigative skills.
Ability to interpret technical and regulatory requirements.
Excellent written and verbal communication skills.
Strong documentation and report-writing abilities.
Ability to work independently while collaborating with regulatory, laboratory, and technical teams.
Strong attention to detail and ability to maintain accurate records.
Ability to travel to laboratory inspection sites throughout California and potentially out of state.
