Medical Laboratory Technologist / Sr Medical Laboratory Scientist (QC), NCIS

National University Hospital; Singapore; On-site; USD 45,000 - 80,000; Full time

Job summary

An innovative healthcare organization is seeking a Quality Control Specialist to join its expanding Stem Cell Therapy Hub. In this pivotal role, you will be responsible for executing various quality control tests, ensuring compliance with stringent regulatory standards, and supporting the development of SOPs. Your expertise will contribute to the enhancement of quality management systems and the delivery of exceptional patient care. If you possess a keen eye for detail and a passion for quality assurance in the pharmaceutical or biotechnology sectors, this position offers a unique opportunity to make a significant impact in a dynamic environment.

Qualifications

• 2-4 years of relevant experience in Quality Control in healthcare.
• Strong knowledge of quality management systems and regulations.

Responsibilities

• Perform routine testing including analytical and microbiological samples.
• Coordinate testing activities and ensure availability of materials.
• Support quality audits and compliance initiatives.

Skills

Quality Control Testing

Analytical Science

Microbiological Testing

Problem-solving

Communication Skills

Education

Bachelor in Science

Pharmacy

Pharmaceutical Science

Job description

Overview*

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialised Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Control (QC) Specialist for the QC department in the organisation.

The candidate will execute the assigned Quality Control Testing (e.g. Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

Job Responsibilities*

Responsible for routine testing which includes analytical, bioanalytical, microbiological and/or environmental samples testing, depending on the technical role assigned.

Coordinating and scheduling of testing activities.

Ensure all critical materials, reagents and consumables required for testing are available.

Coordinate procurement and provide URS of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plasticware etc.

Coordinate shipment of samples and QC materials.

Ensure all laboratory operations including test execution, review and data documentation are performed according to cGMP procedures.

Participate in creating SOP, reviewing SOP, equipment qualification and method verification/validation activities.

Coordinate/Perform calibration and preventive maintenance of laboratory equipment

Initiate quality document such as out of specification investigation, deviation record, change control etc if necessary.

Support in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs.

To support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager.

Participate in method validation/method verification activities which include protocols preparation and review.

Perform trend analysis of test data that are essential for monitoring purpose.

To conduct training as subject matter expert in the test methods, systems and equipment assigned.

Supports improvement initiatives, programs and projects driven from the Quality Management System

Support as subject matter expert during internal and external audits/inspections.

Escalates quality and compliance risks to QC Management and QA.

Any other responsibilities assigned by the QC Management

Note: Other responsibilities may be assigned.

Requirements*

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 2-4 years of relevant work experience in Quality Control role in the pharmaceutical/biotechnology/medical device/healthcare industry.
• Good knowledge of quality control, quality management system and validations requirement, preferably with third party customer/supplier or vendor management experience.
• Good knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy
• Good communication and able to engage stakeholders effectively from different functional units
• Critical thinking and problem-solving skill are of advantage.