GCLP Repository Specialist

southafrica-fhcrc; Cape Town; On-site; ZAR 985,000 - 1,559,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Repository Technician to manage the laboratory biospecimen repository, ensure specimen integrity, and maintain strict GCLP compliance.

You will perform accessioning, storage, retrieval, and chain‑of‑custody documentation, generate thaw lists, oversee cold‑chain logistics, and train staff on SOPs while coordinating with internal teams and external collaborators.

Qualifications

• Bachelor’s degree or equivalent in a relevant biomedical field.
• Minimum 5 years’ experience in a GCLP‑compliant lab.
• Experience with LIMS for specimen management; LDMS and LabWare advantageous.
• Valid IATA certification for international shipments.
• Proficient in MS Office (Excel) and documentation management.

Responsibilities

• Oversee day-to-day operation and organization of the specimen repository, ensuring specimen integrity, traceability, and uninterrupted cold chain management within liquid nitrogen and –80°C storage systems.
• Maintain accurate specimen inventories and records within the Laboratory Information Management System (LIMS), ensuring timely data entry and reconciliation.
• Coordinate specimen requests, retrieval, accessioning, storage, shipment preparation, and distribution of specimens for internal testing and external collaborators.
• Generate and/or QC Master Thaw Lists (MTLs) and Individual Thaw Lists (ITLs) to support laboratory testing activities.
• Monitor repository capacity and optimize storage utilization, archival activities, and disposition of expired specimens.
• Receive, package, ship, and document biological specimens in accordance with IATA regulations and SOPs.
• Track control panels and designated specimens, liaising with stakeholders as required.
• Submit specimen inventory reports and regulatory documentation to the Department of Health.
• Serve as the liaison for repository issues and process improvements.
• Maintain repository SOPs and conduct staff training on repository processes.

Skills

LIMS for specimen management

IATA certification

GCLP standards

MS Office / Excel

Communication skills

Education

Bachelor's degree in Biomedical Technology or equivalent

Tools

SharePoint

Veeva

LabWare

LDMS

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a Repository Technician to manage the laboratory biospecimen repository, ensure specimen integrity, and maintain strict GCLP compliance.

You will perform accessioning, storage, retrieval, and chain‑of‑custody documentation, generate thaw lists, oversee cold‑chain logistics, and train staff on SOPs while coordinating with internal teams and external collaborators.