Clinical Laboratory Scientist - CLS 0921 VG#01

Job Description

Job Description

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.