[Hiring] Pre-Analytical Supervisor @Helix

Role Description

Join Helix's high-volume, CAP/CLIA certified laboratory, where every specimen we process starts a patient's result. As a Pre-Analytical Supervisor, you will lead the team that receives, verifies, accessions, and plates specimens at scale. You will set the standard for that work and grow the people doing it. You will also help the lab keep pace with a growing test volume. This role sits at the intersection of people leadership, laboratory operations, regulatory compliance, and technology.

• Supervise daily pre-analytical operations, from specimen receipt and packing slip verification through visual QC, data entry, plating, and routing to downstream departments.
• Own throughput and turnaround time by tracking workload in real time and adjusting staff assignments before capacity issues escalate.
• Serve as the first point of escalation for pre-analytical exceptions and troubleshoot specimen, system, and process issues raised by staff or downstream teams.
• Lead root-cause investigation of production errors and operational issues, with documentation completed within defined SLA windows.
• Drive continuous improvement that removes waste, reduces variability, and streamlines workflows for high-throughput operations.
• Report TAT, failure rate, success rate, daily throughput, and accuracy to leadership with analysis and recommended action.
• Lead, coach, and develop Lab Technicians through task delegation, workload balancing, and structured performance check-ins.
• Build individual development plans for each direct report, and own hiring, onboarding, scheduling, and shift coverage to match projected volume.
• Own CAP and CLIA inspection readiness for the department, including competency assessments, current SOPs, and corrective actions that fix 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 reach leadership.

Qualifications

• 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.
• Minimum of 2 years of direct supervisory experience in a CAP- or CLIA-certified clinical laboratory, including direct reports and operational accountability.
• Demonstrated working knowledge of CLIA, CAP, HIPAA, and OSHA as they apply to clinical laboratory operations.
• Demonstrated 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, with comfort presenting data to cross-functional stakeholders and senior leadership.
• Proven ability to manage competing priorities, resolve operational issues independently, and drive results in a high-volume, regulated environment.
• Ability to work on 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 using AI tools for reporting and analysis, including verifying outputs against source data.

Requirements

• 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, with knowledge of NYSDOH requirements.
• Experience in precision medicine, clinical genomics, NGS, or molecular diagnostics laboratory settings.
• Prior participation in LIMS implementation, configuration, or optimization projects, with the ability to translate business requirements for technical teams.
• Familiarity with process improvement methodologies (Lean, Six Sigma, or equivalent) 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.

Benefits

• Comprehensive Health Insurance with Date of Hire eligibility. Above average employer paid premium coverage.
• 12 weeks 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: 18 well-being programs covering financial, legal and wellness solutions.
• Flexible PTO.
• Remote options for many roles and a home office stipend.