QUALITY CONTROL ASSISTANT

Cryocord Sdn Bhd; Sepang; On-site; MYR 45,000 - 78,000; Full time

Job summary

Cryocord Sdn Bhd in Malaysia is seeking a Quality Control professional to support the head of Quality in executing QC activities for bioproducts, including CFU assay, flow cytometry, endotoxin and mycoplasma testing, while ensuring ISO15189 and regulatory compliance.

The ideal candidate holds a degree in biotechnology or related field, with at least 1 year of relevant experience; fresh graduates are encouraged to apply and must be able to work independently under supervision.

Qualifications

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

Responsibilities

• Assist the Head of Quality Department in QC activities for products per SOP.
• Conduct QC testing: CFU assay, flow cytometry analysis, endotoxin and mycoplasma testing.
• Ensure ISO15189, MOH license, cGMP compliance; participate in audits and trainings.

Skills

Independent work

Education

Biotechnology / Biology / Medical Science degree

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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.