{"id":3880994,"url":"https://alion.io/job/helix-pre-analytical-supervisor","title":"Pre-Analytical Supervisor","company":{"id":1864201,"name":"Helix","domain":"helix.com","url":"https://alion.io/company/helix-com","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Gem","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":47,"max":60,"currency":"USD","period":"hour","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"HIPAA","optional":false},{"name":"LIMS","optional":false},{"name":"Next-Generation Sequencing","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-05T17:22:51Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T00:04:40Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"You + Helix\nHelix is a place where innovators and doers gather in order to drive significant progress in population genomics. We have come together to work at the intersection of clinical care, research, and genomics.\nIf you're excited by the idea of making a meaningful impact and joining a team where we pride ourselves on driving innovation through fostering an environment with an emphasis on empowering one another to grow, Helix might be the place for you!\nHelix + The World\nHelix is the leading population genomics company. Helix enables health systems, public health organizations and life science companies to accelerate the integration of genomic data into patient care and public health decision making.\nWe are continuing to scale our world-class team to support our dedication to empowering every person to improve their life through DNA.\nHelix + Transparency\nAt Helix, we value transparency. You will find the expected compensation, interview process, what to anticipate during onboarding, and your first 90 days listed in the job description for all Helix roles.\nWhat is special about this role?\nJoin 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.\nAs a Pre-Analytical Supervisor, you will:\nSupervise daily pre-analytical operations, from specimen receipt and packing slip verification through visual QC, data entry, plating, and routing to downstream departments.\nOwn throughput and turnaround time by tracking workload in real time and adjusting staff assignments before capacity issues escalate.\nServe as the first point of escalation for pre-analytical exceptions and troubleshoot specimen, system, and process issues raised by staff or downstream teams.\nLead root-cause investigation of production errors and operational issues, with documentation completed within defined SLA windows.\nDrive continuous improvement that removes waste, reduces variability, and streamlines workflows for high-throughput operations.\nReport TAT, failure rate, success rate, daily throughput, and accuracy to leadership with analysis and recommended action.\nLead, coach, and develop Lab Technicians through task delegation, workload balancing, and structured performance check-ins.\nBuild individual development plans for each direct report, and own hiring, onboarding, scheduling, and shift coverage to match projected volume.\nOwn CAP and CLIA inspection readiness for the department, including competency assessments, current SOPs, and corrective actions that fix root causes.\nInitiate, route, and close change controls and deviations in Veeva QualityOne within 24 hours of identification and within defined quality SLAs.\nPartner with Quality, Customer Service, Software, Lab Operations, Post-Analytical, Supply Chain, and People to resolve issues and lead change management.\nUse AI tools to build and check daily metric reports before they reach leadership.\nAbout you:\nBachelor'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.\nMinimum of 2 years of direct supervisory experience in a CAP- or CLIA-certified clinical laboratory, including direct reports and operational accountability.\nDemonstrated working knowledge of CLIA, CAP, HIPAA, and OSHA as they apply to clinical laboratory operations.\nDemonstrated experience with a laboratory information management system (LIMS), including navigating, troubleshooting, and training others.\nExperience using a quality management system (QMS) for change control and deviation management.\nStrong written and verbal communication, with comfort presenting data to cross-functional stakeholders and senior leadership.\nProven ability to manage competing priorities, resolve operational issues independently, and drive results in a high-volume, regulated environment.\nAbility to work on a computer for at least 50% of the working day, and to stand or sit for extended periods.\nAbility to lift up to 25 pounds occasionally, and to grasp, pinch, and reach as specimen handling requires.\nWillingness to work evenings, weekends, or holidays as operational and coverage needs require.\nGood judgment using AI tools for reporting and analysis, including verifying outputs against source data.\nPluses:\nExperience in a CAP-accredited clinical laboratory, including direct participation in CAP inspection preparation or response.\nExceptional understanding of CAP, CLIA, and state-level laboratory regulations, with knowledge of NYSDOH requirements.\nExperience in precision medicine, clinical genomics, NGS, or molecular diagnostics laboratory settings.\nPrior participation in LIMS implementation, configuration, or optimization projects, with the ability to translate business requirements for technical teams.\nFamiliarity with process improvement methodologies (Lean, Six Sigma, or equivalent) applied to laboratory workflow redesign.\nExperience supporting volume ramps, new test launches, or laboratory expansion initiatives.\nASCP, AMT, or equivalent laboratory certification.\nProject management experience or PMP certification.\nHands-on Veeva QualityOne experience, including initiating change controls, authoring deviations, managing CAPA actions, and maintaining document version control.\nFLSA Status: Exempt\nExpected Interview Process:\n1) Recruiter Screen 2) Manager Screen/Tech Screen 3) Onsite 4) Offer\nExpected Pay For This Role:\nThere are 3 distinct parts to your Helix offer: 1) Base Salary 2) Annual Bonus 3) Equity\nExpected Helix Base: $47 - $60 per hour\nExpected Helix Discretionary Annual Bonus: 10% of your annual salary\nEquity: 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.\nThe 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.\nAside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:\nComprehensive Health Insurance with Date of Hire eligibility. Above average employer paid premium coverage.\n12 weeks Helix Paid Parental Leave option\n401(k) with employer matching of up to 3% and 100% Vesting on the Date of Hire\nComprehensive Well-Being Benefits: 18 well-being programs covering financial, legal and wellness solutions\nFlexible PTO\nRemote options for many roles and a home office stipend\nWhat To Expect During Your Onboarding Week:\nWe 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.\nWhat To Expect During Your First 90 Days:\nBy Day 30:\nUnderstand 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.\nLearn to navigate HAMUI, Labbit, STT, and Linear, and identify process gaps and the challenges they create.\nBuild relationships with team members and department counterparts.\nConfirm CAP and CLIA requirements are upheld, and verify that SOPs accurately capture the process and ensure standardized work.\nConfirm the current staffing model, shift coverage, open requisitions, and training status for OSHA, biosafety, PPE, and HIPAA.\nReview personnel files, training records, Veeva SOP version control, and the quality indicator reporting cadence to Quality.\nBy Day 60:\nIdentify 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.\nUnderstand 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.\nMap 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.\nBuild a staffing model aligned to demand, with hiring, cross-training, and scheduling. \nParticipate in the Quality meeting with metrics and insights, set up quality indicator reporting, and develop a plan for monitoring the functional area.\nIdentify each team member's strengths, set individual growth plans and structured performance check-ins, and track attrition.\nBy Day 90:\nOperate 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.\nOwn daily, weekly, and monthly operational metrics with analysis and recommended action, and confirm production errors are contained with root cause documented within SLA windows.\nImplement the first priority improvements from the Day 60 gap plan, track results against baseline, and communicate process changes to the team before implementation.\nConfirm CAP checklist items are current with no overdue actions, corrective actions are verified effective, and the department participates in an internal or external audit.\nComplete competency assessments on schedule, and close or escalate overdue change controls and deviations within SLA, with documented status to Quality and Lab Operations leadership.\nConfirm every direct report has an active individual development plan.\nTo learn how Helix collects, uses, and protects your personal information during the recruitment process, please review our Privacy Notice.\nHelix is proud to be an equal opportunity employer, and committed to providing employment opportunities regardless of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, pregnancy, childbirth and breastfeeding, age, sexual orientation, military or veteran status, or any other protected classification, in accordance with applicable federal, state, and local laws.\n #LI-Remote\nCompensation\nThe base pay range for this role is $47 - 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