Senior Genomics Validation & Data Quality Lead

Gene by Gene, Ltd.; Houston (TX); Vor Ort; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Medical & Health Savings

Dental & Vision

401(k) Matching

Diverse PTO Framework

Disability & Family Leave

Zusammenfassung

Gene by Gene is seeking a Senior Validations Specialist to lead validation and verification activities for assays, pipelines, and data systems in a regulatory-friendly setting. You will analyze large-scale genomic data, develop QC measures, and document results to ensure accuracy and reliability.

The role requires deep bioinformatics expertise, strong statistics skills, and the ability to collaborate across laboratory, quality, and product teams in a lean, fast-moving environment.

Qualifikationen

• Strong knowledge of bioinformatics tools, pipelines, and genomics databases (NGS, genotyping).
• Experience with Linux/UNIX environments.
• Proficiency in computational and statistical methods for large-scale biological data."
• Understanding of quality control principles and regulatory standards (CLIA, CAP, COLA, NYSDOH, ISO 15189, ISO/IEC 17025).
• Experience drafting validation plans, reports, and SOPs in regulated labs.

Aufgaben

• Design, execute, and document validation/verification studies for assays and pipelines per quality standards.
• Define acceptance criteria, analyze validation data, and prepare validation reports.
• Drive validation activities to completion, remove roadblocks, inform stakeholders of progress and risks.
• Analyze and interpret large-scale biological data; identify patterns and translate findings into recommendations.
• Implement quality control measures and support audits, inspections, and accreditation activities.

Kenntnisse

Bioinformatics tools

Genomics data analysis

Linux/UNIX

Statistics

Documentation

Quality control

Ausbildung

Ph.D. or M.S. in Genetics, Bioinformatics, Computational Biology, or related field

Tools

Bioinformatics platforms

Data analysis software

Jobbeschreibung

Gene by Gene is seeking a Senior Validations Specialist to lead validation and verification activities for assays, pipelines, and data systems in a regulatory-friendly setting. You will analyze large-scale genomic data, develop QC measures, and document results to ensure accuracy and reliability.

The role requires deep bioinformatics expertise, strong statistics skills, and the ability to collaborate across laboratory, quality, and product teams in a lean, fast-moving environment.