Clinical Laboratory Scientist

Job Summary

The Clinical Laboratory Scientist performs high-complexity testing and provides scientific support to ensure accurate, reliable toxicology results in accordance with CLIA Subpart M, Montana licensure requirements, and accreditation standards (COLA/CAP). The CLS contributes to method verification, quality assessment, corrective actions, and training within the toxicology laboratory.

Essential Duties, Responsibilities, and Expectations

High-Complexity Testing & Analytical Interpretation (~35%)

•    Perform, interpret, and validate clinical toxicology assays including LC/MS testing.
•    Ensure analytic accuracy, precision, and adherence to method performance specifications.

Quality Control, Proficiency Testing & Compliance Oversight (~30%)

•    Review QC, calibration results, maintenance logs, and PT performance.
•    Implement and document corrective actions for deviations per 42 CFR §493.1281–1289.
•    Maintain readiness for CLIA inspections and accreditation audits.

Method Verification, Validation & Scientific Support (~20%)

•    Participate in method evaluation studies (accuracy, precision, reportable range).
•    Assist in reagent lot qualifications and parallel testing studies.

Training, Communication & Workflow Coordination (~10%)

•    Provide technical guidance and training to CLTs and new CLS staff.
•    Support SOP revision and documentation processes.

Other Duties as Assigned (~5%)

Minimum Qualifications

•    Must be legally authorized to work in the United States ; Indigenuity does not sponsor visas.
•    Bachelor’s degree in laboratory science, medical technology, chemistry, or biology AND four (4) years of high-complexity testing experience ( per 42 CFR §493.1491 ).
•    Montana CLS licensure (or eligibility).
Certificates, Licenses, Registrations
•    ASCP/AMT certification strongly preferred.

Competencies / KSAs

•    Advanced understanding of analytic chemistry and mass spectrometry.
•    Strong troubleshooting skills and understanding of QC principles.
•    Effective communication and documentation skills.
•    Ability to mentor staff and support scientific decision-making.

Physical Demands & Working Conditions

•    Laboratory environment with biohazard exposure and PPE requirements.
•    Extended periods of standing and repetitive motion.