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

National University Hospital; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading healthcare organization is seeking a Quality Control Specialist to join their QC department. This role involves executing Quality Control Testing, coordinating activities, and maintaining compliance with cGMP procedures. Candidates should possess a Bachelor's degree in Science or related fields and have at least 2-4 years of experience in Quality Control within the pharmaceutical or healthcare sector. Strong knowledge in quality management systems and communication skills are essential. This position is based in Singapore and is a full-time role.

Qualifications

• More than 2-4 years of relevant work experience in a Quality Control role in the pharmaceutical/biotechnology/medical device/healthcare industry.
• Good knowledge in regulations and industrial guidance for stem cell/cell and gene therapy.

Responsibilities

• Execute assigned Quality Control Testing including Raw Material Testing and Environmental testing.
• Coordinate testing activities and ensure availability of materials for testing.
• Perform quality document tasks such as out of specification investigations.

Skills

Knowledge of quality control

Communication skills

Critical thinking

Problem-solving

Education

Bachelor or higher in Science, Pharmacy, Pharmaceutical Science, or equivalent

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.