CLINICAL LABORATORY SCIENTIST JOB DESCRIPTION

A Clinical Laboratory Scientist license is required before day one. That single regulatory fact defines everything about this role: the work touches patient specimens under CLIA and CAP accreditation frameworks, and every result carries a chain of accountability from collection through final report. High complexity testing - including molecular assays, NGS workflows, and quality control cycles - is the daily rhythm here. The role sits within the core laboratory function, answerable to a Laboratory Director or Supervisor, and the accuracy of its output directly shapes clinical decisions made for real patients.

As the Clinical Laboratory Scientist, you own the full scope of high complexity diagnostic testing on patient specimens, ensuring result accuracy, regulatory compliance, and quality assurance under the direction of laboratory leadership. The position operates within a CLIA- and CAP-regulated clinical laboratory, collaborating with laboratory directors, supervisors, and R&D or assay development teams depending on the setting.

Career Impact: Holding a state CLS license and hands-on experience with NGS platforms and molecular techniques places you in a credential class that opens doors to senior scientist, laboratory lead, and assay development roles within healthcare and diagnostics.

Business Impact: Every corrective action documented, every QC failure caught before a patient result is released, and every SOP kept current reduces diagnostic error rates that clinicians and patients depend on.

Growth Opportunity: Exposure to instrument validation, assay configuration, and proficiency testing programs builds the technical portfolio that Laboratory Director and Molecular Biology Scientist positions require.

• Perform high complexity laboratory testing on patient specimens according to written standard operating procedures.
• Review, interpret, and report patient results within the laboratory information management system to ensure timely turnaround.
• Troubleshoot assay and instrument failures, documenting all corrective actions when systems deviate from established performance specifications.
• Monitor and execute quality control procedures, maintaining records that meet the standards of accrediting agencies.
• Validate and qualify reagents per approved protocols, maintaining sufficient inventory for daily laboratory operations.
• Conduct or support instrument validation, proficiency testing, and internal audit preparation activities.
• Maintain and revise standard operating procedures under the direction of laboratory leadership.
• Mentor or supervise unlicensed laboratory personnel and support competency documentation at required intervals.

• Bachelor's degree in Clinical Laboratory Science, Biology, Chemistry, Biochemistry, Molecular Biology, or equivalent work experience.
• 1 or more years of clinical laboratory experience, with demonstrated competency in moderate to high complexity testing.
• Valid state Clinical Laboratory Scientist (CLS) license or Clinical Genetic Molecular Biologist Scientist (CGMBS) license.
• Working knowledge of CLIA, CAP, HIPAA, and applicable federal and state laboratory regulations.
• Demonstrated ability to perform specimen processing, quality control documentation, and corrective action protocols.
• Strong organizational skills with a high degree of accuracy, attention to detail, and ability to manage multiple simultaneous tasks.
• Ability to work independently under minimal supervision and collaborate effectively across laboratory teams.

• ASCP certification with a molecular or medical technology background, reflecting additional credentialing beyond state licensure.
• Experience with NGS platforms, microarray analysis, or other high-throughput molecular techniques used in clinical diagnostics.
• Familiarity with laboratory automation systems, LIMS configuration, and statistical process control methods.
• Prior involvement in assay development, instrument qualification, or laboratory validation projects supporting new diagnostic tests.

• Proficiency testing scores, measuring accuracy of results against external reference standards each cycle.
• QC out-of-range rate per instrument, reflecting how consistently established performance specifications are maintained.
• Corrective action documentation turnaround time, measuring how quickly deviations are recorded and resolved.
• SOP review completion rate, tracking whether annual procedure reviews are completed within required timeframes.
• Sample rejection rate, indicating the proportion of specimens flagged before processing reaches final reporting.
• Typical tools: Laboratory information management systems (commonly LIMS platforms); molecular instrumentation (commonly NGS and PCR-based systems).

• Base Salary Range: $70,000 to $95,000 annually, varying by state, seniority, and setting.
• Bonus: Annual performance bonus of 3% to 8% where offered, more common in commercial labs.
• Equity: Rarely offered except in early-stage biotech or diagnostics start-ups.
• Health Benefits: Medical, dental, and vision coverage standard; employer contribution varies.
• PTO: 15 to 20 days annually, plus standard federal holidays.
• Common Perks: Continuing education reimbursement, licensure renewal support, shift differential for evening or weekend rotations.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Background checks, including criminal history and where applicable drug screening, are a condition of employment for all laboratory positions. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the hiring process and during employment. Candidates must hold current authorization to work in the United States.

The Clinical Laboratory Scientist owns end-to-end high complexity laboratory testing, including Next Generation DNA sequencing and quality assurance procedures on patient specimens, ensuring compliance with all applicable local, state, and federal requirements. Reporting to the Laboratory Supervisor, the role delivers accurate patient results through LIMS while supporting assay improvements and training of new laboratory personnel.

Key Responsibilities

• Perform laboratory tests, procedures and analyses per the laboratory's standard operating procedures.
• Review, interpret and report patient results in LIMS.
• Independently identify and troubleshoot high complexity problems that adversely affect the test performance.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
• Assist with training of new laboratory personnel.
• Maintain sufficient inventory of laboratory supplies for daily operations and prepare reagents required for testing.
• Perform and document reagent qualification per the approved protocols.
• Perform annual review of Standard Operating Procedures.
• Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.
• Participate in introduction of assay improvements, new assay configurations and validation.

Education & Experience

• Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field.
• California Clinical Laboratory Scientist license.
• Working knowledge of local, state, and federal laboratory regulations.
• Able to integrate and apply feedback in a professional manner.
• Able to prioritize and drive to results with a high emphasis on quality.
• Ability to work as part of a team.

Embedded within the clinical laboratory team, the Clinical Laboratory Scientist I delivers moderate to highly complex analytical testing on clinical specimens under the direction of the Laboratory Medical Director, supporting quality assurance, equipment maintenance, and accurate documentation. Working closely with laboratory personnel and leadership, this role shapes specimen processing workflows and contributes to quality management system compliance across regulatory and accreditation standards.

Core Functions

• Perform moderate and/or highly complex analytic processes without direct supervision.
• Interpret problems with specimens that meet the rejection criteria for unacceptable samples, make the decision to reject a sample and request recollection to ensure validity of results.
• Operate laboratory instruments and ensure proper functioning of laboratory equipment.
• Complete and document required maintenance activities on equipment, recognize and escalate potential issues by reporting service needs to leadership for resolution.
• Perform quality control procedures as specified and maintain quality control records and documentation necessary to meet the standards of accrediting agencies.
• Prepare specimens for analysis and determine acceptability of samples within guidelines.
• Assist in developing procedures for specimen collection, handling and transport to maintain specimen integrity and viability.
• Validate acceptability of test results by reviewing test parameters and identify the technical, instrumental and/or physiologic causes of unexpected test results.
• Monitor quality assurance and assist in data collection and preparation of QA indicators.
• Perform internal and external proficiency testing, handling proficiency testing samples in the same manner as patient samples.
• Maintain clean and orderly work area, cleaning bench surfaces and equipment each shift or after contamination or spill.
• Participate in continuing education and staff meetings, prepare and present continuing education programs for department personnel as requested.
• Contribute to design, research, review and writing of laboratory manuals, remaining informed of procedure updates and changes.
• Comply with safety and hazard regulations, understand, maintain and enforce safety guidelines.
• Observe principles of data security and patient confidentiality, maintaining ethical standards in the performance of testing and in interactions with patients, co-workers and other health care professionals.
• Support and comply with the Quality Management System policies and procedures.

Minimum Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Molecular Biology, Clinical Laboratory Sciences, or a similar laboratory intensive life sciences degree, including a minimum of 6 Chemistry credits, 6 Biology credits and a combined total of 24 credits in Chemistry and Biology.
• 6+ months of laboratory experience, which may include laboratory coursework, internship(s), and/or research assistantship.
• 1+ years of experience working in a clinical laboratory setting.
• Experience in molecular testing.
• Regular and reliable attendance.
• Ability to work overtime and outside assigned schedule as needed.
• Ability to lift up to 40 pounds for approximately 25% of a typical working day.
• Ability to work seated and standing for approximately 50% of a typical working day each.
• Ability to work in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
• Ability and means to travel 5% between laboratory locations.
• Ability to comply with any applicable personal protective equipment requirements.

Reporting to laboratory leadership, the Clinical Laboratory Scientist leads diagnostic and research operations for an infectious diseases laboratory, ensuring CAP accreditation standards and all institutional regulatory requirements are met and maintained. Partnering with research and clinical teams, this role builds new diagnostic test capabilities through assay validation while delivering advanced data analysis and interpretation that directly supports patient care outcomes.

Primary Duties

• Function as a clinical laboratory scientist for the Naval Infectious Diseases Diagnostic Laboratory, ensuring standards and requirements for College of American Pathologist (CAP) accreditation and all institutional regulatory requirements are met and maintained.
• Oversee staff performing clinical laboratory assays for infectious diseases in an accurate and timely manner following written standard operating procedures.
• Accurately perform all quality testing to ensure accuracy of results as specified by regulatory agencies and supervisory review, and handle personally identifiable information following HIPAA standards.
• Direct laboratory research projects, including collection and organization of data, generating reports, presentations, and manuscripts.
• Make detailed observations about experiments and troubleshoot assays in compliance with the quality management plan.
• Develop new diagnostic tests and take a lead role in validating new diagnostic assays to be used for patient care.
• Prepare technical reports, summaries, and protocols.
• Maintain clear and accurate laboratory records, inventories, and logbooks.
• Perform and analyze data entry for assays and projects and maintain databases.
• Maintain supplies in the laboratory and keep the laboratory area clean.
• Provide advanced data analysis and interpretation.

Required Qualifications

• PhD degree in Molecular Biology, Biology, Biochemistry or equivalent discipline.
• ASCP Certification is a plus.
• 4-5 years of virology laboratory experience.
• Advanced experience in virology and assay development preferred.
• Significant clinical laboratory experience preferred.
• Must be willing and able to endure long periods of standing and sitting as well as handling various chemicals.
• Must be willing and able to acquire, at a minimum, a SECRET classification access level.
• US citizenship is required due to federal contract requirements.

Sitting at the intersection of laboratory operations and regulatory compliance, the Clinical Laboratory Scientist I delivers quality assurance activities including instrument validation, proficiency testing, and internal audits while supervising unlicensed laboratory personnel. Operating across specimen preparation, reagent management, and inspection readiness functions, this role builds a compliant and well-maintained laboratory environment aligned with California state licensure requirements.

Duties

• Perform laboratory tests, procedures and analyses according to standard operating procedures.
• Perform, review and document laboratory quality control procedures.
• Operate, maintain and troubleshoot laboratory equipment.
• Prepare reagents required for laboratory testing.
• Participate in instrument validation, proficiency testing, and quality assurance activities.
• Utilize good documentation practices and follow laboratory safety policies.
• Supervise the work of clinical laboratory assistants and unlicensed laboratory personnel.
• Perform quality assurance activities for internal audits and inspection preparation.
• Maintain sufficient inventory of laboratory supplies for daily operations.

Education & Experience

• Bachelor's Degree in Medical Technology, related field, or equivalent.
• Must possess a valid California State Clinical Laboratory Scientist (Generalist) or Clinical Genetic Biologist Scientist License.
• Completion of a CLS training program at an accredited institution or clinical laboratory.
• 1 year of experience working in a clinical laboratory.
• Strong understanding of good laboratory practices and regulatory compliance, including working knowledge of local, state, and federal laboratory regulations.
• Computer skills such as word processing, statistical analysis, and laboratory information systems.
• Laboratory automation skills preferred.
• Ability to analyze and problem solve basic issues that impact test performance.
• Excellent verbal and written communication skills.

A key member of the transfusion services team, the Clinical Laboratory Scientist I delivers accurate testing of blood products and donor samples, including CBC and pH analysis, while managing blood component preparation and proficiency testing reporting. Collaborating across laboratory operations, this role shapes the quality and safety of blood product release, quarantine, and send-out processes that directly support patient care.

Functions

• Properly use the Blood Product Information System, authorize and perform system overrides as needed and within scope of authority, and escalate system problems to management as encountered.
• Accurately perform testing of blood products and donor samples, including hematology counts (CBC) and pH.
• Accurately record, interpret, and report test results, recognizing and appropriately handling unacceptable test results.
• Verify acceptability of blood samples.
• Prepare and pack blood samples for send-out testing.
• Properly perform quality control and preventative maintenance of laboratory equipment.
• Perform blood component preparation from whole blood and apheresis collections.
• Label blood products and perform quarantine, destruction, and release of blood products.
• Prepare, perform, and report proficiency testing.
• Evaluate blood component QC testing.

Qualifications & Experience

• High school diploma or comparable education.
• Bachelor's degree in biological, physical, or chemical sciences or medical technology preferred.
• Current state CLS licensure.
• MT (ASCP) preferred.
• At least 1 year of previous CLS working experience.
• Blood donor center or transfusion service experience is a plus.
• Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.

Accurate andrology and reproductive laboratory outcomes depend on the Clinical Laboratory Scientist, who leads semen analysis, endocrinology testing, and IVF preparation procedures while maintaining laboratory records and quality management program participation. Based within a clinical laboratory setting, this role delivers quality control monitoring and KPI oversight that supports the laboratory's reproductive medicine service standards.

Accountabilities

• Perform semen analysis and endocrinology testing.
• Prepare semen for intrauterine insemination and IVF.
• Perform semen cryopreservation and storage.
• Maintain accurate laboratory records.
• Perform quality control procedures and monitor KPIs.
• Participate in the laboratory's quality management program.

Skills & Qualifications

• Must have CLS certification.
• 1+ years of experience in a clinical laboratory setting, with preference for andrology.
• Familiarity with the Beckman Access 2 analyzer preferred.
• Able to work independently with minimal supervision.
• Exceptionally detail-oriented with a high level of accountability and proven track record of taking ownership and solving problems.
• Strong communication and interpersonal skills, with the ability to build cross-functional relationships.
• Team player and collaborator with exceptional follow-through.
• Comfortable in a fast-paced, rapidly changing environment with the ability to flex into responsibilities outside of role.
• Weekend and holiday rotation required.
• Willingness to be flexible.

As the Clinical Laboratory Scientist, this role shapes complex molecular diagnostic testing procedures across all qualified specimen types, operating under minimal supervision while serving as the primary resource for microarray technology including RNA labelling, hybridization, and scanning. The laboratory relies on this work to maintain LIMS data integrity, SOP compliance across OSHA, CLIA, HIPAA, and ISO 13485 frameworks, and continuity of patient confidentiality and ethical standards.

Day-to-Day Responsibilities

• Serve as a resource for microarray technology, including labelling RNA, hybridizing, washing and scanning microarrays.
• Perform diagnostic laboratory activities on the basis of standard operating procedures.
• Compose and revise Standard Operating Procedures under the direction of the Lab Director, Lab Ops Director or Lab Manager.
• Consult with the Lab Director, Lab Ops Director or Lab Manager regarding the daily workflow of the clinical laboratory and troubleshooting.
• Perform all aspects of laboratory procedures following safety guidelines and adhering to protocols as pertains to health and safety policies and procedures.
• Take responsibility for assigned projects, including instrument comparisons, instrument calibrations, staff schedules, process improvement, lab training and competency, and assay or instrument validation.
• Maintain a filing system for completed patient data and register results and data in lab journal and LIMS.
• Assist other personnel and departments when requested.
• Initiate own career development by staying familiar with current literature and seeking out seminars, workshops and professional meetings.
• Adhere to applicable federal and state laws, regulations and guidelines including OSHA, CLIA, CAP, GLP, GCP, HIPAA, and ISO 13485.
• Exhibit ethical and professional behavior and maintain patient confidentiality at all times.

Professional Experience

• Bachelor's degree required, advanced degree preferred.
• California Clinical Laboratory Scientist (CLS), Clinical Genetic Molecular Biologist Scientist (CGMBS) License, or any other specialist license that can perform high complexity molecular testing.
• 6+ years of clinical laboratory experience with a Bachelor's degree, 4+ years with a Master's degree, or 2+ years with a doctoral degree.
• Experience with molecular diagnostic techniques, histology techniques, microarray analysis, working with databases, quality systems, lab automation, and statistical analysis and/or software.
• Exceptional knowledge of DNA/RNA extractions, PCR and RT-PCR reactions, DNA sequencing and other molecular genetic techniques.
• Advanced technical knowledge of Microsoft products including Excel, Word, and Outlook.
• Strong organizational skills, attention to detail, and high degree of accuracy.
• Ability to manage multiple tasks independently with excellent problem resolution skills.
• Excellent customer service skills and strong verbal and written communication.
• General accounting and math skills with strong analytical thinking and research skills.
• Ability to read and extract information from a pathology report.

Clinical Laboratory Scientist delivers high complexity molecular testing across specimen processing, NGS library construction, PCR, gel electrophoresis, and sequencing workflows according to established standard operating procedures, under the direction of the Laboratory Director. The work directly supports patient result accuracy by maintaining quality control programs, automation workstation operations, and timely corrective action documentation within a regulated biotech laboratory environment.

Role Responsibilities

• Perform routine molecular test procedures in an assigned area such as specimen processing, nucleic acid extraction, quantitative analysis, gel electrophoresis, PCR, library construction, sequencing and data analysis according to the laboratory's standard operating procedures.
• Perform and document routine preventive maintenance and reagent qualification according to approved protocols or SOPs.
• Operate high-throughput integrated automation workstations and use in-house LIMS and other infrastructure software during performance of job duties.
• Assist in resolving technical problems and ensure that corrective actions are taken whenever test systems deviate from the laboratory established performance specifications.
• Maintain accurate records of work performed and perform or monitor instrument calibration and maintenance records.
• Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
• Assist in training and competency documentation of testing personnel at the required intervals.
• Monitor and maintain quality control and quality assessment programs.
• Create and revise lab SOPs as needed.

Background & Experience

• BS Degree in Medical Technology, Biology, Chemistry, or related sciences preferred.
• Valid California CLS Generalist or Specialty in Microbiology license or Clinical Chemist Scientist license.
• ASCP certification with strong molecular background preferred.
• Working knowledge of relevant laboratory regulations and experience with software and automation systems.
• Experience with highly complex molecular testing preferred.
• Experience with high sample volumes, NGS platforms, six sigma, lean manufacturing, GMP/GLP/CLIA/CAP/ISO, and software specification development is a plus.
• Molecular Biology experience strongly recommended.
• Ability to work independently and collaboratively with team members.
• Highly goal-driven with demonstrated ability to effectively prioritize and focus on time-sensitive objectives.
• Strong problem-solving skills, excellent teamwork and motivation skills, and strong sense of creativity.
• Excellent organizational, record-keeping and communication skills, both verbal and written.
• Strong work ethic to generate high quality work under tight deadlines.

The Clinical Laboratory Scientist owns specimen processing, quality control execution, and regulatory compliance documentation within a CLIA/CAP regulated environment, ensuring all patient test results meet established performance specifications. Reporting to the laboratory lead or supervisor, this role delivers accurate laboratory outcomes by maintaining LIMS workflows, troubleshooting assay and equipment failures, and escalating protocol deviations that could impact patient care.

Scope of Work

• Perform specimen processing, maintain quality test performance, and report test results.
• Use LIMS to perform sample management, testing worklists, and data reporting.
• Ensure compliance with all regulatory agency requirements through proper documentation.
• Select, implement, and evaluate results for Quality Control materials used in statistical process control of laboratory assays.
• Procure and perform quality control testing of reagents as needed.
• Troubleshoot assays and equipment for which QC metrics fail to meet criteria.
• Participate in activities required to support all necessary licensure for the clinical laboratory, including quality management functions and on-site inspections.
• Participate in audits and assist in assay development activities as required.
• Recognize, document, and escalate lab protocol deviations to the laboratory lead or supervisor.
• Contribute to updating work instructions and operating procedures to accurately reflect practices.
• Maintain understanding of the scientific methods employed within the laboratory.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

Knowledge Skills & Abilities

• Bachelor's degree with 0-1 years of experience in a clinical laboratory setting.
• Current California Laboratory Scientist (CLS) or CGMBS license or equivalent.
• Able to perform high complexity tests in a highly regulated CLIA/CAP environment including analytical and post-analytical processes.
• Ability to multi-task and prioritize duties to meet turnaround times that directly impact patient care.
• Ability to read, understand, and comply with detailed procedures that ensure the safety of all personnel.
• Detail-oriented, conscientious and possessing a strong sense of ownership in one's work.
• Excellent communication and ability to work as part of a cohesive team.
• Capable of identifying problems that may adversely affect test performance or reporting of test results, and correcting the problem or immediately notifying the general supervisor.

Embedded within a highly automated clinical laboratory, the Clinical Laboratory Scientist builds and maintains patient sample processing workflows using an automated testing platform, exercising independent judgement under minimal supervision while mentoring unlicensed Production Laboratory Scientists and CGMBS Trainees. Working closely with engineering and R&D teams, this role advances instrument qualification, troubleshooting, and validation of new instrumentation and assays to uphold the highest standards of quality and accuracy.

Key Deliverables

• Work in a team environment and independently as necessary.
• Process patient samples using an automated platform with independent judgement and minimal supervision.
• Perform setup, teardown, and preventative maintenance on laboratory equipment.
• Perform quality control procedures and prepare reagents for use on laboratory equipment.
• Archive and retrieve patient samples.
• Work with the engineering team to troubleshoot instrument issues.
• Document any procedure deviations or instrumentation malfunctions.
• Communicate with co-workers to ensure smooth and efficient workflow.
• Perform qualification protocols for recently repaired instruments.
• Identify problems that may adversely affect test performance or reporting of test results, correcting the problems or immediately notifying the laboratory leadership team.
• Follow protocols and document corrective actions taken when instruments deviate from established performance specifications.
• Assist R&D teams in the development and validation of new instrumentation or assays.
• Adhere to the laboratory's quality control policies.

Position Requirements

• A BS or BA degree in a chemical, physical, biological, clinical laboratory science, or medical technology from an accredited institution.
• A valid clinical laboratory scientist license or clinical genetics molecular biology scientist license issued by the State of California.
• Experience with laboratory operations and procedures.
• A working understanding of good laboratory practices and regulatory compliance.
• Accurate pipetting skills and basic computer proficiency.
• The ability to adapt and be flexible in a fast-paced and evolving work environment.
• The ability to work diligently with minimal supervision.
• Excellent written and verbal communication skills.
• Punctuality and professionalism.

Reporting to laboratory management, the Clinical Laboratory Scientist leads molecular assay setup, DNA/RNA extraction, and NGS instrument operations on Illumina NextSeq and MiSeq platforms within a clinical molecular analysis environment. Partnering with the laboratory team, this role delivers accurate test result reporting and SOP implementation that supports the quality and integrity of molecular diagnostic services.

Operational Focus

• Extract DNA/RNA from human samples.
• Set up molecular assays including PCR and qPCR.
• Perform quality testing of reagents and maintenance of instrumentation.
• Report laboratory test results.
• Review and implement technical instructions and standard operating procedures.
• Run NGS instruments including Illumina NextSeq and MiSeq.

Experience & Qualifications

• Bachelor's degree in Biology or a related area.
• Current California clinical laboratory scientist (CLS) license.
• 1-2 years of experience in a clinical molecular analysis or research lab.
• Demonstrated molecular biology lab techniques.
• Highly organized and detail oriented.
• Able to work independently and follow instructions.