Pre-Analytical Supervisor

Helix • San Diego, CA

2d • $47 - $60

About The Position

Helix is hiring a Pre-Analytical Supervisor to lead its high-volume, CAP/CLIA-certified laboratory team responsible for receiving, verifying, accessioning, and plating specimens. The role sets standards for pre-analytical work and develops the people performing it, while helping the lab scale to meet growing test volume. It combines people leadership, laboratory operations, regulatory compliance, and technology.

The supervisor oversees end-to-end pre-analytical operations, monitors throughput and turnaround time, troubleshoots exceptions, leads investigations and continuous improvement, and reports operational metrics to leadership. The role also leads and develops Lab Technicians, manages hiring and staffing coverage, maintains CAP and CLIA inspection readiness, and oversees quality-system activities such as change controls and deviations. The supervisor partners with cross-functional teams and uses AI tools to prepare and verify daily metric reports.

The position is classified as exempt. Helix lists expected base compensation of $47–$60 per hour, a discretionary annual bonus of 10% of annual salary, and equity. Actual starting compensation depends on job-related factors including work location, experience, training, education, and skills. Helix describes remote options for many roles but does not specify this role's work arrangement.

Requirements

• Bachelor's degree in Clinical Laboratory Science, Biological Sciences, Medical Technology, or a closely related scientific field; an associate degree with significant relevant experience will also be considered.
• At least 2 years of direct supervisory experience in a CAP- or CLIA-certified clinical laboratory, including direct reports and operational accountability.
• Working knowledge of CLIA, CAP, HIPAA, and OSHA as applied to clinical laboratory operations.
• Experience with a laboratory information management system (LIMS), including navigating, troubleshooting, and training others.
• Experience using a quality management system (QMS) for change control and deviation management.
• Strong written and verbal communication skills, including comfort presenting data to cross-functional stakeholders and senior leadership.
• Ability to manage competing priorities, independently resolve operational issues, and drive results in a high-volume, regulated environment.
• Ability to work at a computer for at least 50% of the working day and to stand or sit for extended periods.
• Ability to lift up to 25 pounds occasionally and to grasp, pinch, and reach as specimen handling requires.
• Willingness to work evenings, weekends, or holidays as operational and coverage needs require.
• Good judgment when using AI tools for reporting and analysis, including verifying outputs against source data.

Nice To Haves

• Experience in a CAP-accredited clinical laboratory, including direct participation in CAP inspection preparation or response.
• Exceptional understanding of CAP, CLIA, and state-level laboratory regulations, including knowledge of NYSDOH requirements.
• Experience in precision medicine, clinical genomics, NGS, or molecular diagnostics laboratory settings.
• Participation in LIMS implementation, configuration, or optimization projects, with ability to translate business requirements for technical teams.
• Familiarity with Lean, Six Sigma, or equivalent process improvement methodologies applied to laboratory workflow redesign.
• Experience supporting volume ramps, new test launches, or laboratory expansion initiatives.
• ASCP, AMT, or equivalent laboratory certification.
• Project management experience or PMP certification.
• Hands-on Veeva QualityOne experience, including initiating change controls, authoring deviations, managing CAPA actions, and maintaining document version control.

Responsibilities

• Supervise daily pre-analytical operations, including specimen receipt, packing slip verification, visual QC, data entry, plating, and routing to downstream departments.
• Monitor workload, throughput, and turnaround time in real time and adjust staff assignments to address capacity needs.
• Act as the first escalation point for pre-analytical exceptions and troubleshoot specimen, system, and process issues.
• Lead root-cause investigations of production errors and operational issues, ensuring documentation is completed within defined SLA windows.
• Drive continuous improvement to reduce waste and variability and streamline high-throughput workflows.
• Report turnaround time, failure rate, success rate, daily throughput, and accuracy to leadership, including analysis and recommended actions.
• Lead, coach, and develop Lab Technicians through delegation, workload balancing, and structured performance check-ins.
• Create individual development plans for direct reports and manage hiring, onboarding, scheduling, and shift coverage in line with projected volume.
• Maintain CAP and CLIA inspection readiness, including competency assessments, current SOPs, and corrective actions that address root causes.
• Initiate, route, and close change controls and deviations in Veeva QualityOne within 24 hours of identification and within defined quality SLAs.
• Partner with Quality, Customer Service, Software, Lab Operations, Post-Analytical, Supply Chain, and People to resolve issues and lead change management.
• Use AI tools to build and check daily metric reports before they are shared with leadership.

Benefits

• Comprehensive health insurance with eligibility from date of hire and above-average employer-paid premium coverage.
• 12 weeks of Helix paid parental leave option.
• 401(k) with employer matching of up to 3% and 100% vesting on the date of hire.
• Comprehensive well-being benefits, including 18 programs covering financial, legal, and wellness solutions.
• Flexible PTO.
• Remote options for many roles and a home office stipend.
• Discretionary annual bonus of 10% of annual salary.
• Equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager