GRAIL
Clinical Laboratory Specialist V (Data Review & Quality) #4901
Durham, NC · Full-time
Sponsorship not specifiedDetected 1 day ago
GCPData ScienceClinical TrialsClinical Laboratory TechniquesFDA RegulatoryBioinformaticsMolecular BiologyNGSMedical DevicesCommunicationCollaboration
About the role
- 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.
- 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.
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.
- Perform technical assessment of molecular assay performance across multiple workflow stages, including specimen quality, library preparation, sequencing performance, contamination monitoring, and downstream analytical outputs.
- 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.
- Contribute to continuous improvement initiatives by identifying opportunities to optimize post-analytical review processes, data assessment workflows, quality practices, and report release procedures.
- Support implementation, verification, or validation activities associated with assay updates, software changes, pipeline modifications, or quality process improvements as assigned.
- 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.
- Maintain an organized, inspection-ready work environment while adhering to laboratory safety, biosafety, and data integrity requirements.
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.
- Demonstrated knowledge of applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance.
Nice to have
- 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.
- Experience supporting regulated clinical laboratory operations, quality systems, and audit readiness activities.
- This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire
Compensation
- The expected, full-time, annual base pay rate for this position is $33.65/hour - $39.42/hour.
This listing is sourced directly from GRAIL's careers page and normalized into a canonical job model.