K User
@kuser15
I lead compliant biospecimen operations and quality systems in regulated labs.
United StatesWhat I'm looking for
I’m a clinical laboratory and compliance leader with 8+ years driving operations across biotechnology, oncology diagnostics, clinical trials, and biorepository environments. I specialize in biospecimen governance, laboratory operations, and regulatory compliance in CAP/CLIA, GLP, GMP, and GCP-regulated settings.
In my latest role as a QC Sample Management Supervisor, I lead end-to-end QC sample management to ensure 100% traceability across receipt, storage, distribution, and disposition. I supervise and develop cross-functional teams, strengthen environmental monitoring and preventive controls, and run deviation investigations and CAPA using formal quality systems.
Previously, as an HBS Compliance Manager, I reviewed and codified approximately 500,000 human biological samples and served as a subject matter expert on HBS governance and compliant sample utilization. I’ve also led high-throughput specimen processing in multi-cancer early detection programs, supported validation activities, authored SOPs and work instructions, and used laboratory automation and molecular workflows to improve quality, efficiency, and compliance.
Experience
Work history, roles, and key accomplishments
QC Sample Management Supervisor
Oct 2025 - Present (9 months)
Led end-to-end QC sample management operations ensuring traceability across receipt, storage, distribution, and disposition activities. Supervised a cross-functional sample management team and implemented environmental monitoring and deviation/CAPA activities to maintain regulatory readiness.
Managed human biological sample (HBS) compliance by reviewing and codifying approximately 500,000 samples to align use with informed consent provisions. Authored and maintained SOPs governing HBS review processes using Veeva Vault and supported risk mitigation for compliant biobank operations.
Supervised high-throughput specimen operations supporting multi-cancer early detection programs, including pre-analytical workflow design integrating automation and LIS systems. Authored SOPs/work instructions for quality initiatives and contributed to validation activities involving approximately 9,000 clinical samples.
Processed approximately 1,600 specimens using Hamilton, Roche Cobas, and Ziath automation platforms for cancer biomarker assessment initiatives. Performed cfDNA extraction, DNA quantification, protein assays, and quality control, and managed biorepository functions including accessioning, inventory tracking, and storage while maintaining GLP and CAP/CLIA compliance.
Coordinated multiple concurrent dermatology research projects, using confocal microscopy to generate and analyze imaging data. Identified testing variances, implemented procedural modifications to improve reliability, and supported compliance with institutional policies and regulatory standards.
Education
Degrees, certifications, and relevant coursework
Madonna University
Bachelor of Science, Microbiology
Earned a Bachelor of Science (B.Sc.) in Microbiology from Madonna University in Rivers State, Nigeria.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring K?
You can contact K and 90k+ other talented remote workers on Himalayas.
Message KGet matched with your dream remote job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
