Quality Assurance Specialist (Clinical Genomics)

About 3billion

3billion is a leading genetic diagnostic company dedicated to ending the diagnostic odyssey for children and other patients with rare genetic diseases. We are a global pioneer in AI-driven genetic diagnostics, leveraging our proprietary bioinformatics pipeline to deliver rapid, accurate Exome (ES) and Genome Sequencing (GS) tests. Having successfully served patients and physicians in over 75 countries, we are now entering a new chapter: launching our first US clinical laboratory in Austin, Texas. Joining now means founding-team ownership: you will help build our US lab's people, processes, and culture from day one, backed by a platform already delivering results worldwide. We are looking for a dedicated and meticulous Quality Assurance Specialist to be the regulatory force supporting our diagnostic engine. If you are passionate about quality and want your daily work to directly impact the lives of children and families waiting for answers, join us. Discover more about our global impact at https://3billion.io/ (opens in a new tab)

Role Overview

As the Clinical Genomics Quality Assurance Specialist, you will own and oversee the daily operation of our Quality Management System (QMS) as we establish our new high-complexity clinical genomics laboratory in Austin, TX. You will be a key pillar in ensuring that all molecular diagnostics, high-throughput sequencing pipelines, and Laboratory Developed Tests (LDTs) are fully compliant with federal and multi-state regulations. Your rigorous oversight ensures the accuracy, reliability, and regulatory compliance of every test we run. By bridging the clinical laboratory, bioinformatics, and the variant interpretation and reporting teams, you ensure our genomic testing meets the highest industry standards, both when it is validated for clinical use and throughout ongoing clinical operations. This full-time role is ideal for a quality expert who thrives in a fast-moving startup. You will build an audit-ready QMS that protects data integrity, supports our state-by-state expansion, and advances our mission to end the diagnostic odyssey for children and other patients with rare diseases. As one of our first US hires, you will build quality systems from the ground up, and the role will evolve as we grow.

Core Responsibilities

• • Regulatory Compliance & Accreditation: Own laboratory accreditation and licensure (CLIA, CAP, NYS CLEP, California CDPH) from initial approval through ongoing maintenance, including inspection readiness, periodic renewals, new applications, and test approval submissions.
• • Audit & Inspection Readiness: Act as the primary liaison between the clinical laboratory and accrediting agencies. Perform regular internal quality audits across all laboratory sections and coordinate timely resolution of any audit findings.
• • QMS & Document Control: Administer the document control and incident reporting systems. Manage the lifecycle of all Standard Operating Procedures (SOPs), software release documentation, validations, and quality logs.
• • Deviation & CAPA Management: Review and follow up on nonconformances and clinical deviations until resolution. Initiate Corrective and Preventive Actions (CAPA) to address system deficiencies, proactively mitigate quality risks, and drive implementation of corrective action plans.
• • Assay Validation & System Compliance: Ensure lab systems are operating in compliance with regulations, including IQ/OQ/PQs, calibrations, and maintenance for high-throughput sequencing platforms and automated liquid handlers. Oversee NYS CLEP submissions for new validations.
• • Personnel & Proficiency Oversight: Ensure proper qualification of laboratory personnel according to regulatory standards, managing documentation of competency and training. Direct the implementation, enrollment, and performance monitoring of all proficiency testing (PT) programs.
• • Quality Metrics & KPIs: Develop dashboards for monthly reporting of key performance indicators (KPIs), trend quality metrics, and recommend continuous improvements that complement existing practices.

Required Qualifications

• • Education: Bachelor's degree or higher in medical technology, laboratory sciences, molecular biology, genetics, or a closely related scientific discipline.
• • Experience: A minimum of 8 years of experience in clinical laboratories performing high-complexity testing, with at least 5 years dedicated to CAP/CLIA Quality Management, accreditation requirements, and applicable regulations.
• • Regulatory Expertise: Deep operational experience navigating NYS CLEP and California CDPH state laboratory requirements for LDTs and NGS applications.
• • Technical Skills: In-depth understanding of high-throughput NGS workflows and bioinformatics analysis pipelines. Demonstrated ability to exercise good judgment and problem-solve on an interdisciplinary team.

Preferred Qualifications

• • Advanced Regulatory Experience: Experience working in an FDA-regulated industry (medical device/IVD) and familiarity with GCP/GCLP regulations in support of clinical trials are highly preferred.
• • Certification & Licensure: MB(ASCP), ASQ certification (CQA, CMQ/OE, or CCLQP), CLS, or CGMBS license is highly desirable.
• • Pediatric Testing: Experience supporting quality programs for pediatric or rapid-turnaround genomic testing.

Why Join Us? (Compensation & Benefits)

We offer a competitive compensation package and, through a US Professional Employer Organization (PEO), comprehensive benefits:

• • Medical, Dental, and Vision coverage for you and your family
• • 401(k) retirement plan
• • PTO, paid sick leave, and company holidays

3billion US, Inc. is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by law.

If you need a reasonable accommodation to apply or interview, contact jobs@3billion.io.

Employment offers are contingent on a background check, conducted after a conditional offer and in accordance with applicable law, including the Fair Credit Reporting Act. The check includes verification of education, licensure, and certifications.