QUALITY CONTROL ASSISTANT

Assist the Head of Quality Department and his/her assigned nominees) on the following (but not limited to) matters:-

• Responsible in the operational techniques and activities used to fulfill the requirements for quality control.
• Conduct quality control activities for the products of the Company in accordance to the SOP i.e. colony-forming unit (CFU) assay, flow cytometry analysis, etc.
• Conduct testing for Bacterial Endotoxin and Mycoplasma for all relevant product in the company.
• Conduct quality control testing for products (Mesenchymal Stem Cells, CAR-T, etc).
• Adhere to the SOP at all times as well as ensure compliance with the safety and health regulations of the laboratory at all times.
• Manage and monitor the internal quality controls and the Inter-laboratory Comparison programmes such as external quality assessment programmes or proficiency testing programmes.
• Prepare and record the data analysis for all quality control tests.
• Ensure the validation analyses for cleaning, disinfectant, gowning, process and personnel are carried out accordingly.
• Check the calibration data of equipment or facilities given by internal and external parties.
• Conduct and monitor environmental testing for the facilities.
• Responsible in the continual improvement of the Quality Management System.
• Perform other related laboratory processes such as viability tests, cell culture, blood cell count, etc.
• Maintain all standards as per requirements of the ISO15189, MOH License, cGMP and other certifications/accreditations.
• Participate in internal and external audits as well as regulation inspections.
• Provide adequate trainings to new and existing employees in the department from time to time.
• Other duties as and when requested by the Company.

DESIRED SKILLS & EXPERIENCE

• Degree in Biotechnology, Biology, Medical Science, or related field.
• Minimum 1 year of relevant working experience/ Fresh graduates are also encouraged to apply.
• Able to work independently with minimal supervision.