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.