Repository Technician

Position Purpose:

The Repository Technician is responsible for maintaining the laboratory biospecimen repository, managing laboratory equipment, and ensuring strict compliance with Good Clinical Laboratory Practice (GCLP) standards.

This operational role involves hands-on specimen accessioning, storage, retrieval, inventory reconciliation, and chain-of-custody documentation to ensure the absolute integrity and traceability of biological specimens.

KEY RESPONSIBILITIES:

Repository (50%)

• Oversee the day-to-day operation and organization of the laboratory 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, inventory reconciliation, system updates, and liaison with laboratory staff and vendors as required.
• Coordinate specimen requests and perform hands-on retrieval, accessioning, storage, shipment preparation, and distribution of specimens for internal testing and external collaborators, ensuring timely communication of sample availability, shipment schedules, and any discrepancies.
• Generate and/or quality control (QC) Master Thaw Lists (MTLs) and Individual Thaw Lists (ITLs) to support laboratory testing activities.
• Monitor repository capacity and implement strategies to optimize storage utilization, including repository reorganization, specimen consolidation, archival activities, and disposition of expired or obsolete specimens.
• Receive, package, ship, and document biological specimens in accordance with IATA regulations, GCLP requirements, sponsor requirements, and laboratory SOPs.
• Track CTAC sample controls, competency panels, locked specimens, and specimens designated for ICS, QFT, and other laboratory assays, liaising with internal and external stakeholders as required.

· Maintain and ensure timely submission of all required specimen inventory reports and regulatory documentation to the Department of Health.

· Serve as the main liaison for the laboratory and repository related issues or process improvements.

· Serve as the document owner for repository-related SOPs, ensuring procedures remain current and conducting staff training on repository processes as required.

Equipment Maintenance (20%)

• Coordinate the repository maintenance, calibration, qualification, and servicing of laboratory equipment to ensure operational readiness and continued compliance with GCLP and laboratory quality standards.
• Monitor repository equipment performance, maintenance schedules, service records, and associated documentation, identifying trends and coordinating corrective actions where necessary.
• Coordinate repository equipment procurement, repairs, troubleshooting, and vendor service visits as required.
• Liaise with suppliers to ensure the continuous availability of liquid nitrogen, dry ice, gases, and other critical laboratory consumables.
• Provide general support and backup support for all other laboratory equipment maintenance, calibration, qualification, and servicing from designee.
• Maintain equipment-related SOPs and provide training to laboratory personnel on equipment operation and maintenance requirements
• Ensure laboratory equipment and associated activities comply with institutional safety policies and regulatory requirements.

Laboratory Operations and Safety (20%)

• Serve as the Laboratory Safety Officer, promoting compliance with laboratory safety policies, GCLP, and Environmental Health and Safety (EHS) requirements. Provide On-call and after-hours laboratory support by responding to urgent issues and ensuring continuity of critical lab operations and equipment.
• Conduct laboratory risk assessments, safety inspections, and follow-up activities to ensure a safe working environment.
• Support compliance of the specimen repository and specimen processing laboratory with institutional and regulatory safety requirements.
• Coordinate and deliver laboratory safety training and maintain associated training records.

GCLP Compliance (10%)

• Perform quality control reviews of repository, equipment, and safety documentation to ensure compliance with GCLP, laboratory SOPs, and applicable regulatory requirements.
• Draft, review, revise, and maintain laboratory SOPs and controlled documents within the quality management system.
• Prepare, maintain, and organize documentation required to support internal audits, external audits, inspections, and sponsor visits.
• Represent repository, equipment, and safety functions during internal and external audits, implementing corrective and preventive actions (CAPAs) where applicable.

Other duties as assigned.

Work Location: In person