Lab Manager
Job Summary
Lead the regulatory, operational, and technical development of a new CLIA moderate-complexity laboratory within a multidisciplinary regenerative and longevity center. This strategic role involves build-out oversight, compliance system architecture, equipment validation, and scaling operations post-launch. Guide team development and ensure readiness for inspections and ongoing excellence.
Essential Functions
- Architect lab compliance systems and coordinate licensing with state and federal regulators
- Lead equipment procurement, vendor selection, and IQ/OQ/PQ validation
- Build quality management infrastructure including SOPs, competency programs, and audit readiness
- Oversee LIS implementation and integration with EMR systems
- Provide input on lab design, workflow layout, HVAC, and safety equipment
- Develop proficiency testing enrollment, QC tracking, and incident reporting protocols
- Supervise testing personnel and conduct internal audits post-launch
- Scale test menu and operations strategically based on facility needs
Required Qualifications
- Bachelor’s degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, or Chemistry
- MLS (ASCP) or equivalent certification
- Minimum 5 years of experience in moderate complexity laboratories
- Prior participation in CLIA inspections
- Knowledge of CLIA regulations (42 CFR 493), state lab licensing, and OSHA safety standards
- Experience with quality management systems and proficiency testing oversight
Preferred Qualifications
- Experience with laboratory start-up or expansion projects
- Background in specialty biomarker or functional testing
- Prior implementation of LIS interfaces and HL7 integrations
Technical Skills
- CLIA compliance and inspection preparation
- Laboratory quality management systems
- Equipment validation (IQ/OQ/PQ)
- LIS/EMR integration and HL7 interfaces
- SOP development and competency assessment
- Proficiency testing and QC tracking
- Lab design and workflow optimization
- Regulatory licensing applications
- Internal auditing and incident reporting
- Team supervision in clinical settings
Education & Certifications
Bachelor’s degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, or Chemistry required. MLS (ASCP) or equivalent certification strongly preferred.
Compensation & Benefits
Base salary range of $105,000 to $135,000 annually for Las Vegas market, initially as 1099 contract with transition to W-2. Potential bonuses tied to inspection readiness and timeline milestones. Standard benefits provided upon full-time conversion for regulatory continuity.