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
