Quality Assurance Specialist – Clinical Genomics
Location: Austin, TX
Work Arrangement: 100% Onsite
Employment Type: Full-Time
Schedule: Monday–Friday, 1st Shift
About the Opportunity
Lighthouse Lab Services is partnering with an innovative genetic diagnostics organization to identify an experienced Quality Assurance Specialist for its growing clinical genomics laboratory in Austin, Texas.
This organization specializes in advanced genetic testing for patients with rare and complex genetic conditions. Through next-generation sequencing (NGS), whole-exome sequencing (WES), whole-genome sequencing (WGS), and advanced bioinformatics technology, the company helps physicians identify the genetic causes of rare diseases and provide answers to patients and families who may have spent years searching for a diagnosis.
This is a unique opportunity to join an organization during the establishment of its first U.S. clinical laboratory. The selected candidate will play a critical role in building the laboratory's Quality Management System (QMS), establishing regulatory processes, and ensuring the laboratory is prepared for accreditation and ongoing clinical operations.
Position Overview
The Quality Assurance Specialist will oversee the development, implementation, and daily administration of the laboratory's Quality Management System. This individual will be responsible for maintaining regulatory compliance across high-complexity molecular diagnostics, next-generation sequencing workflows, and laboratory-developed tests (LDTs).
Working closely with laboratory leadership, bioinformatics specialists, and clinical teams, the Quality Assurance Specialist will ensure that laboratory processes, documentation, testing systems, and quality programs meet applicable federal and state regulatory requirements.
This role will have significant ownership of laboratory accreditation, inspection readiness, document control, corrective and preventive actions, and ongoing quality improvement initiatives.
The ideal candidate will bring extensive experience with CAP/CLIA quality management, clinical molecular diagnostics, and state-specific laboratory regulations, particularly New York and California requirements. Experience helping establish quality systems in a new or rapidly growing laboratory environment would be especially valuable.
Key Responsibilities
Regulatory Compliance & Accreditation
Oversee laboratory accreditation, licensure, and regulatory compliance activities, including CLIA, CAP, New York State CLEP, and California CDPH requirements.
Coordinate initial applications, renewals, test approval submissions, and ongoing regulatory maintenance.
Maintain inspection readiness and ensure laboratory operations meet applicable federal and state requirements.
Serve as a primary point of contact for accrediting and regulatory agencies.
Monitor regulatory changes and communicate their potential impact on laboratory operations and testing services.
Quality Management System (QMS) & Document Control
Develop, implement, and maintain the laboratory's Quality Management System.
Administer document control systems and oversee the lifecycle of laboratory documentation.
Maintain and review standard operating procedures (SOPs), validation records, software release documentation, and quality logs.
Ensure documentation is accurate, current, appropriately approved, and readily available for regulatory inspections.
Establish and maintain quality processes that support the laboratory's growth and expansion into additional markets.
Audits, Inspections & Corrective Actions
Coordinate and support internal and external quality audits and regulatory inspections.
Perform routine quality audits across laboratory departments to evaluate compliance and identify areas for improvement.
Investigate nonconformances, clinical deviations, and quality events.
Lead or coordinate corrective and preventive action (CAPA) activities, including root cause analysis, corrective action implementation, and effectiveness checks.
Track audit findings and ensure corrective actions are completed within established timelines.
Identify potential quality risks and proactively implement measures to prevent recurring issues.
Assay Validation & Laboratory Systems Compliance
Ensure laboratory equipment, instruments, and systems meet applicable regulatory and quality requirements.
Oversee documentation and compliance related to installation, operational, and performance qualification (IQ/OQ/PQ).
Monitor calibration, maintenance, and quality control requirements for sequencing platforms and automated liquid handling equipment.
Support regulatory submissions and validation documentation for new laboratory-developed tests.
Coordinate applicable New York State CLEP submissions for new test validations.
Work with laboratory and technical teams to ensure validation activities are properly documented and meet regulatory expectations.
Personnel Qualifications & Proficiency Testing
Ensure laboratory personnel meet applicable education, training, and competency requirements.
Oversee documentation of employee qualifications, training, and competency assessments.
Coordinate proficiency testing (PT) enrollment, implementation, and ongoing performance monitoring.
Ensure proficiency testing activities are properly documented and reviewed.
Identify and address quality or training gaps related to personnel performance.
Quality Metrics & Continuous Improvement
Develop and maintain quality dashboards and key performance indicators (KPIs).
Monitor and trend quality metrics to identify recurring issues and opportunities for improvement.
Prepare periodic quality reports for laboratory leadership.
Recommend and implement process improvements to strengthen laboratory performance and regulatory compliance.
Collaborate with laboratory leadership, bioinformatics, and clinical teams to maintain consistent quality standards across testing and reporting workflows.
Required Qualifications
Bachelor's degree or higher in Medical Technology, Medical Laboratory Science, Laboratory Sciences, Molecular Biology, Genetics, or a closely related scientific discipline.
Minimum of 8 years of experience working in clinical laboratories performing high-complexity testing.
At least 5 years of dedicated experience in CAP/CLIA quality management, laboratory accreditation, and regulatory compliance.
Extensive experience with clinical laboratory quality systems and regulatory requirements.
Strong working knowledge of New York State CLEP and California CDPH laboratory requirements, particularly as they relate to laboratory-developed tests and next-generation sequencing applications.
Understanding of high-throughput NGS workflows and bioinformatics analysis pipelines.
Demonstrated experience managing audits, inspections, nonconformances, and corrective and preventive action programs.
Experience developing, maintaining, and administering laboratory quality documentation and SOPs.
Strong analytical, organizational, and problem-solving skills.
Ability to collaborate effectively with laboratory operations, technical teams, bioinformatics specialists, and clinical leadership.
Preferred Qualifications
Experience in an FDA-regulated environment, including medical devices or in vitro diagnostics (IVD).
Familiarity with Good Clinical Practice (GCP) or Good Clinical Laboratory Practice (GCLP) requirements supporting clinical trials.
MB(ASCP) certification.
ASQ certification, such as Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Certified Clinical Laboratory Quality Professional (CCLQP).
California Clinical Laboratory Scientist (CLS) or Clinical Genetics Molecular Biologist Scientist (CGMBS) license.
Experience supporting quality programs for pediatric or rapid-turnaround genomic testing.
Previous experience helping establish a Quality Management System within a new clinical laboratory or startup environment.
Compensation & Benefits
The organization offers a competitive compensation package, including:
Medical, dental, and vision insurance for employees and eligible family members.
401(k) retirement plan.
Paid time off.
Paid sick leave.
Company holidays.
Why Consider This Opportunity?
This is an opportunity to play a foundational role in establishing the quality and regulatory infrastructure of a growing clinical genomics laboratory.
You'll have the ability to build quality systems from the ground up, influence regulatory strategy, and work alongside experts in molecular diagnostics, genetics, and bioinformatics.
For an experienced laboratory quality professional, this position offers the opportunity to take ownership of a critical function within an organization working at the forefront of genetic diagnostics and precision medicine.
Interested? Apply today or contact Lighthouse Lab Services to learn more about this opportunity.
About Us
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 22 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual
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