CLS QC Lab

Clinical Laboratory Scientist (CLS)

Duration: 36 Months Location: 850 Marina Bay Parkway, Richmond, CA 94804 and 320 4th Street #890, Los Angeles, CA 90013 Notes:

Locations: Richmond and Los Angeles, California, with travel throughout California and potentially out of state. The RFP identifies LFS office locations at 850 Marina Bay Parkway, Richmond, CA 94804 and 320 4th Street #890, Los Angeles, CA 90013. Services are also performed in laboratory settings during site reviews and inspections.

Position Overview: The California Department of Public Health is seeking experienced, currently licensed Clinical Laboratory Scientists (CLS) to support the Laboratory Field Services program within the Center for Laboratory Sciences. This is a specialized CLS opportunity combining clinical laboratory science with regulatory compliance, laboratory inspection, quality assurance, investigation and technical consultation. The CLS will work under the general direction of an Examiner III and support CDPH's responsibility for oversight of licensed clinical laboratories and physician office laboratories. California requires LFS to inspect licensed clinical laboratories at least every two years, with the inspection program operating within both California laboratory law and federal Clinical Laboratory Improvement Amendments (CLIA) requirements.

Mandatory Requirements

1. Current California CLS License Candidate must possess a current State of California Clinical Laboratory Scientist license issued by the California Department of Public Health. The solicitation allows CLS personnel with a Generalist or Specialist License.
2. Education Graduation from college with a major in an appropriate scientific field is required. Recruiters should capture: Degree, Major, College/university, Graduation year.
3. Minimum 3 Years of Relevant Experience The RFP specifically requires at least three years of experience in one or more of the following: Field consultation in clinical laboratories, Field consultation in public health laboratories, Supervision of professional laboratory staff, Service as a laboratory director, Staff specialist work in technical areas of clinical laboratory sciences, Staff specialist work in technical areas of public health laboratory sciences. This requirement is especially important. A candidate having three years of general bench CLS experience alone should not automatically be assumed to satisfy it unless the resume demonstrates experience fitting one of the areas above.
4. Regulatory Knowledge Must have working knowledge of clinical laboratory procedures and policies necessary to comply with California and federal laboratory regulations.

Key Responsibilities The Clinical Laboratory Scientist will support CDPH Laboratory Field Services in evaluating and promoting compliance across California's regulated laboratory environment. Responsibilities include:

Conduct onsite inspections of clinical laboratories and physician office laboratories.

Evaluate laboratory operations for compliance with California Business and Professions Code requirements and federal CLIA requirements.

Conduct complaint investigations.

Perform follow-up inspections to verify that identified deficiencies have been corrected.

Review laboratory survey and inspection reports.

Interpret applicable State and federal laboratory laws and regulations.

Consult with field surveyors regarding compliance issues.

Coordinate laboratory inspection schedules.

Serve as a subject matter expert regarding laboratory regulations.

Communicate findings during laboratory exit interviews.

Prepare formal deficiency reports.

Review laboratory corrective actions.

Maintain and update regulatory and compliance information in State and federal databases.

Provide technical assistance to laboratories.

Respond to technical and regulatory inquiries from laboratories, the public and other stakeholders.

Participate in legal proceedings associated with laboratory sanctions.

Prepare documentation supporting enforcement actions.

Attend required CDPH training.

Prepare technical and regulatory reports.

Assist with updating procedures and work instructions.

Perform laboratory QA/QC activities.

Prepare and upload reports for dissemination of laboratory data and test results.

Verify specimen adequacy.

Perform complex laboratory analyses as required.

Validate test results through correlation with appropriate testing parameters.

Maintain complete, organized and defensible records.

Prepare accurate data packages and reports.

Assist supervisors with technical laboratory consultations.

Develop and/or prepare Standard Operating Procedures (SOPs).

Present research findings at scientific meetings when required.

Protect confidential information and State assets and comply with applicable policies and laws.

Travel Requirement Candidates must be comfortable traveling. The RFP specifically states that travel is required for day trips and overnight trips, both within California and out of state. Recruiters should confirm travel willingness before presenting a candidate.

Highly Preferred Background; For this particular engagement, prioritize candidates who have worked as: Clinical Laboratory Scientist, Senior Clinical Laboratory Scientist, Lead Clinical Laboratory Scientist, CLS Generalist, CLS Specialist, Clinical Laboratory Supervisor, Laboratory Supervisor, Laboratory Manager, Clinical Laboratory Manager, Laboratory Director, Assistant Laboratory Director, Public Health Laboratory Scientist, Public Health Microbiologist with qualifying CLS licensure, Laboratory Quality Manager, Laboratory Compliance Specialist, Laboratory Regulatory Specialist, Laboratory Surveyor, Laboratory Inspector, CLIA Inspector / Surveyor, Laboratory Accreditation Specialist, Laboratory Consultant.

Compu-Vision Consulting Inc.