Location: Billings, Montana
Department: Laboratory Operations
Job Title: Laboratory Manager (Technical & General Supervisor TS/GS)-Toxicology
Reports To: Laboratory Director
Position Status: Full-Time Contract
Supervises: Clinical Laboratory Scientists (CLS), Clinical Laboratory Technicians (CLT), Testing Personnel
Laboratory Manager-Toxicology Job Summary:
The Laboratory Manager provides combined technical, scientific, and operational supervision for a CLIA-certified high-complexity toxicology reference laboratory. This role fulfills technical and general supervisor responsibilities.
The Laboratory Manager ensures accurate testing performance, oversees method validation, maintains regulatory compliance, supervises personnel, conducts competency evaluations, manages workflow, and supports quality and accreditation requirements.
This position plays a critical leadership role to ensure reliable, compliant, and high-quality toxicology services that support patient care and organizational goals.
Responsibilities of the Laboratory Manager-Toxicology:
Technical & Scientific Oversight (~35%)
- Selects, evaluates, and approves test methodologies appropriate for clinical toxicology.
- Establishes and verifies performance specifications (accuracy, precision, analytical sensitivity/specificity, reportable range).
- Ensures reliable operation of LC/MS and other high-complexity systems.
- Reviews and interprets QC, maintenance logs, and performance trends.
- Oversees method validation, assay improvements, and instrument optimization.
Regulatory Compliance, Quality System Oversight & Proficiency Testing (~30%)
- Ensures compliance with CLIA, CMS, Montana laboratory licensure, OSHA, and accrediting bodies (CAP or COLA).
- Maintains inspection readiness; oversees regulatory documentation and corrective actions.
- Ensures PT enrollment, evaluates PT performance, and implements required corrective measures.
- Ensures SOPs are accurate, up-to-date, reviewed annually, and followed consistently.
- Oversees reagent lot validations, calibrations, and quality assurance studies.
Personnel Supervision, Competency & Training (~20%)
- Supervises CLS and CLT staff, ensuring appropriate delegation and task assignment.
- Conducts competency assessments per CLIA requirements (initial, 6-month, 12-month, and annually).
- Provides staff training on analytic systems, QC, troubleshooting, and SOPs.
- Evaluates employee performance and identifies professional development needs.
- Ensures adherence to safety and compliance protocols.
Operational Management & Workflow Coordination (~10%)
- Manages daily workflow to ensure turnaround time (TAT) expectations are met.
- Coordinates equipment service, supply management, and vendor relations.
- Assists with scheduling, coverage planning, and resource allocation.
- Supports LIS integration, data integrity, and documentation standards.
Other Duties as Assigned (~5%)
- Assists the Laboratory Director with audits, investigations, and special projects.
- Participates in meetings and consultative discussions with internal/external stakeholders.
Minimum Qualifications for the Laboratory Manager-Toxicology:
- Candidate must be legally authorized to work in the United States
- Montana licensure required
- Experience must include high-complexity toxicology, preferably with LC/MS
Required Education & Experience (CLIA Technical Supervisor Requirements) for the Laboratory Manager-Toxicology:
Must meet one of the qualification pathways for Technical Supervisor, such as:
- Doctoral degree in chemical, physical, biological, or clinical laboratory science + 1 year of high-complexity experience; OR
- Master’s degree in a related science + 2 years high-complexity experience; OR
- Bachelor’s degree in a related science + 4 years high-complexity laboratory experience.
Preferred Experience:
- Supervisory or management experience in a toxicology clinical laboratory setting.
- Experience in method validation, quality systems, and regulatory compliance.
- Experience with LC/MS maintenance, troubleshooting, and assay development.
Required Licensure/Certification for the Laboratory Manager:
- Montana Clinical Laboratory Scientist license (or eligibility), if required by state law.
- ASCP, AMT, or equivalent preferred.
Competencies/Knowledge, Skills, and Abilities (KSAs)
Technical Competencies:
- Advanced knowledge of LC/MS systems and toxicology assay workflows.
- Expertise in method validation, accuracy/precision studies, and QC evaluation.
- Ability to analyze complex technical data and performance trends.
Regulatory & Compliance Competencies:
- Strong understanding of CLIA, CMS, OSHA, HIPAA, and accreditation requirements.
- Ability to maintain inspection readiness and manage regulatory documentation.
Supervisory & Operational Competencies:
- Effective leadership and communication skills.
- Ability to train, mentor, and evaluate staff.
- Strong organizational and workflow management abilities.
Behavioral Competencies:
- Professionalism, accountability, and attention to detail.
- Cultural competence and contribution to a supportive workplace culture.
Physical Demands & Working Conditions:
- Work performed in a clinical laboratory environment.
- Routine exposure to chemicals and biohazards; PPE required.
- Standing, pipetting, instrument operation, and repetitive tasks required.
- Lifting up to 25 pounds occasionally.
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