Medical Laboratory Technologist

1 day ago

Singapore National University Polyclinics Full time

Medical Laboratory Technologist / Sr Medical Laboratory Scientist (QC), NCIS
Job ID: 8282
Job Function: Allied Health
Institution: National University Hospital
Overview
NCIS 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.
Requirements
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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