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.
Key Responsibilities:
- 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
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
Competitive compensation with potential bonuses tied to key milestones; standard benefits upon transition to full-time.