Medical Laboratory Technologist
3 weeks ago
Job ID: 8282
Job Function: Allied Health
Institution: National University Hospital
OverviewNCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of its expansion of specialised programmes, aiming to become a Reference Centre of Excellence. We are seeking a Quality Control (QC) Specialist for the QC department.
The candidate will perform assigned Quality Control Testing, including Raw Material Testing, In-process testing, Final Product Testing, and other analytical activities related to Cellular Therapy and Haematopoietic Stem Cell Transplant services.
Job Responsibilities- Perform routine analytical, microbiological, and environmental testing based on assigned technical roles.
- Coordinate and schedule testing activities.
- Ensure availability of critical materials, reagents, and consumables.
- Coordinate procurement and provide User Requirements Specifications (URS) for QC materials.
- Manage sample and QC material shipments.
- Ensure laboratory operations comply with cGMP procedures, including test execution, review, and data documentation.
- Participate in SOP creation, review, equipment qualification, and method validation activities.
- Coordinate and perform calibration and preventive maintenance of laboratory equipment.
- Initiate quality documents such as investigations, deviations, and change controls when necessary.
- Support issue resolution, discrepancy investigations, and CAPA implementation.
- Assist in reviewing protocols, reports, SOPs, and other documents.
- Participate in method validation and verification activities, including protocol preparation and review.
- Perform trend analysis of test data for monitoring purposes.
- Conduct training as a subject matter expert on test methods, systems, and equipment.
- Support improvement initiatives within the Quality Management System.
- Assist during internal and external audits/inspections as a subject matter expert.
- Escalate quality and compliance risks to QC Management and QA.
- Perform other responsibilities as assigned by QC Management.
- Bachelor's degree or higher in Science, Pharmacy, Pharmaceutical Science, or related fields; 2-4+ years of relevant QC experience in the pharmaceutical, biotech, medical device, or healthcare industry preferred.
- Strong knowledge of quality control, quality management systems, and validation requirements, with experience in vendor management advantageous.
- Understanding of regulations and industry guidance, especially for stem cell, gene, and cell therapies.
- Effective communication skills and stakeholder engagement across functions.
- Critical thinking and problem-solving skills are advantageous.
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