What is special about this role?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.
As a Pre-Analytical Supervisor, you will:- 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.
About you:- 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.
Pluses:- 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.
FLSA Status: Exempt
Expected Interview Process:1) Recruiter Screen 2) Manager Screen/Tech Screen 3) Onsite 4) Offer
Expected Pay For This Role:There are 3 distinct parts to your Helix offer: 1) Base Salary 2) Annual Bonus 3) Equity
Expected Helix Base: $47 - $60 per hour
Expected Helix Discretionary Annual Bonus: 10% of your annual salary
Equity: We offer generous equity at Helix. If you receive a Helix offer your recruiter will book dedicated time with you to educate you on our equity model.
The salary range above is our reasonable estimate of the base compensation for this role across US locations. Actual starting pay will be based on non-discriminatory job-related factors, including exact work location, experience, relevant training and education, and skill level. Your recruiter can share more about your specific work location salary range during the hiring process.
Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great 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
What To Expect During Your Onboarding Week:We want to make sure your first week is spent learning the foundations. You will be invited to live orientation sessions and spend time with your hiring manager developing your individual roadmap to success. This experience will include sessions that cover your benefits, security & privacy training, an introduction to the OKR framework used at Helix and our communication tools and norms.
What To Expect During Your First 90 Days:By Day 30:- Understand Pre-Analytical Operations (accessioning and plating), the order and sample receipt workflow, the different specimen types, research versus diagnostic work, partner complexity, and the downstream and upstream workflows.
- Learn to navigate HAMUI, Labbit, STT, and Linear, and identify process gaps and the challenges they create.
- Build relationships with team members and department counterparts.
- Confirm CAP and CLIA requirements are upheld, and verify that SOPs accurately capture the process and ensure standardized work.
- Confirm the current staffing model, shift coverage, open requisitions, and training status for OSHA, biosafety, PPE, and HIPAA.
- Review personnel files, training records, Veeva SOP version control, and the quality indicator reporting cadence to Quality.
By Day 60:- Identify and rank process gaps by severity and risk to patient testing. Build a plan to address each one. Apply Lean Six Sigma and 5S concepts.
- Understand Veeva deviations, change controls, CAPAs, and effectiveness checks, and sign off on all Accessioning and Plating processes, including the understanding technical challenges behind common-cause troubleshooting.
- Map CAP checklist items and CLIA competency requirements in pre-analytical scope, confirm each is current, and prepare an audit evidence package for review with Quality.
- Build a staffing model aligned to demand, with hiring, cross-training, and scheduling.
- Participate in the Quality meeting with metrics and insights, set up quality indicator reporting, and develop a plan for monitoring the functional area.
- Identify each team member's strengths, set individual growth plans and structured performance check-ins, and track attrition.
By Day 90:- Operate as the technical standard-setter for the team, able to step into any pre-analytical role as a SME, and represent the department in cross-functional projects such as test launches, volume ramps, or system implementations.
- Own daily, weekly, and monthly operational metrics with analysis and recommended action, and confirm production errors are contained with root cause documented within SLA windows.
- Implement the first priority improvements from the Day 60 gap plan, track results against baseline, and communicate process changes to the team before implementation.
- Confirm CAP checklist items are current with no overdue actions, corrective actions are verified effective, and the department participates in an internal or external audit.
- Complete competency assessments on schedule, and close or escalate overdue change controls and deviations within SLA, with documented status to Quality and Lab Operations leadership.
- Confirm every direct report has an active individual development plan.
CompensationThe base pay range for this role is $47 - $60 per hour.
