Clinical Laboratory Specialist V (Data Review & Quality) #4901

Grail•Durham, NC

10d•Onsite

About The Position

GRAIL's mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. The Clinical Laboratory Specialist V is responsible for advanced post-analytical review activities supporting high-throughput clinical genomics testing within a regulated CLIA/CAP laboratory environment. This role focuses on comprehensive review of assay and bioinformatics-generated data following completion of laboratory and computational workflows to ensure accuracy, integrity, and quality of patient results prior to report release. The individual performs detailed technical assessments of sequencing and assay performance metrics, evaluates data quality trends, investigates discrepancies, and supports timely and compliant report release activities. The role requires strong molecular biology and next-generation sequencing (NGS) knowledge, excellent analytical skills, and the ability to independently assess complex laboratory data within established quality and regulatory standards. This position operates as an individual contributor within the clinical laboratory and plays a critical role in ensuring high-confidence patient reporting through rigorous data review and quality oversight. This position works on-site full-time at our office located in Durham, NC

Requirements

Bachelor’s degree in a life science field with 3+ years of experience in a high-complexity clinical laboratory environment, preferably supporting molecular diagnostics or next-generation sequencing (NGS) testing.
Experience with post-analytical data review, assay quality assessment, clinical genomics workflows, or laboratory quality review activities preferred.
Demonstrated understanding of molecular biology principles, NGS assay workflows, sequencing quality metrics, and clinical laboratory data interpretation.
Demonstrated knowledge of applicable regulatory standards commensurate with the position’s complexity and scope, contributing to organizational regulatory compliance.
Minimal applicable standards include: Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
Operations within a regulated medical device environment (e.g., IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
Development and operations within a regulated clinical study environment (e.g., ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Nice To Haves

MB (ASCP) certification highly preferred
Strong technical expertise in molecular diagnostics and next-generation sequencing (NGS) workflows.
Strong analytical and critical-thinking skills with the ability to independently assess complex laboratory and bioinformatics-generated data.
Demonstrated ability to identify data quality issues, interpret assay performance trends, and apply technical judgment within established review frameworks.
Detail-oriented with strong organizational and documentation skills in regulated laboratory environments.
Proficiency with laboratory information systems (LIMS), quality management systems, and data review platforms.
Effective communication and collaboration skills across laboratory, bioinformatics, quality, and reporting functions.
Ability to manage multiple priorities and maintain accuracy in a high-throughput operational environment.
Experience supporting regulated clinical laboratory operations, quality systems, and audit readiness activities.

Responsibilities

Perform comprehensive post-analytical review of clinical laboratory data generated from high-throughput genomics workflows, including assessment of sequencing quality metrics, assay performance indicators, and bioinformatics pipeline outputs prior to report release.
Evaluate laboratory and computational quality control metrics to ensure accuracy, completeness, consistency, and integrity of patient results in accordance with established laboratory procedures and regulatory requirements.
Review batch-level and sample-level data following bioinformatics processing to identify technical issues, quality concerns, assay anomalies, or unexpected performance trends requiring further investigation or escalation.
Support clinical report release activities by verifying data quality, confirming review completion, and ensuring all required documentation and quality checks are satisfied before final authorization.
Perform technical assessment of molecular assay performance across multiple workflow stages, including specimen quality, library preparation, sequencing performance, contamination monitoring, and downstream analytical outputs.
Investigate routine and non-routine data discrepancies by applying molecular biology knowledge, assay expertise, and analytical reasoning to determine potential root causes and appropriate resolution pathways.
Accurately document review findings, quality observations, deviations, and follow-up actions within laboratory information management systems (LIMS), quality systems, and other regulated documentation platforms.
Collaborate with laboratory operations, bioinformatics, quality, and reporting teams to resolve data quality issues, support turnaround time objectives, and maintain operational continuity within high-volume testing environments.
Participate in quality monitoring activities, including trend analysis, quality metric tracking, and identification of recurring workflow or assay performance issues that may impact result quality or laboratory efficiency.
Contribute to continuous improvement initiatives by identifying opportunities to optimize post-analytical review processes, data assessment workflows, quality practices, and report release procedures.
Maintain compliance with all applicable regulatory, quality, and laboratory standards, including CLIA, CAP, NYSDOH, ISO 15189, and FDA requirements related to clinical laboratory testing and electronic records.
Support implementation, verification, or validation activities associated with assay updates, software changes, pipeline modifications, or quality process improvements as assigned.
Maintain an organized, inspection-ready work environment while adhering to laboratory safety, biosafety, and data integrity requirements.