Assistant - Quality Control
Assistant - Quality Control
Assist the Head of Quality Department and his/her assigned nominee(s) on the following (but not limited to) matters:-
i. Responsible in the operational techniques and activities used to fulfill the requirements for quality control.
ii. 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.
iii. Adhere to the SOP at all times as well as ensure compliance with the safety and health regulations of the laboratory at all times.
iv. Manage and monitor the internal quality controls and the Inter-laboratory Comparison programmes such as external quality assessment programmes or proficiency testing programmes.
v. Prepare and record the data analysis for all quality control tests.
vi. Ensure the validation analyses for cleaning, disinfectant, gowning, process and personnel are carried out accordingly.
vii. Check the calibration data of equipment or facilities given by internal and external parties.
viii. Conduct and monitor environmental testing for the facilities.
ix. Responsible in the continual improvement of the Quality Management System.
x. Perform other related laboratory processes such as viability tests, cell culture, blood cell count, etc.
xi. Maintain all standards as per requirements of the ISO15189, MOH License, cGMP and other certifications/accreditations.
xii. Participate in internal and external audits as well as regulation inspections.
xiii. Provide adequate trainings to new and existing employees in the department from time to time.
xiv. Other duties as and when requested by the Company.
Other Tasks:
i. Conduct testing for product Mesenchymal Stem Cells ie colony forming unit-Fibroblast (CFU-F) assay, cells differentiation, Immunophenotyping, Microsatellite Instability Testing and Immunoassay
ii. Conduct testing for product CAR-T cells ie Replication Competent Lentiviral (RCL)
iii. Conduct testing for Bacterial Endotoxin and Mycoplasma for all relevant product in the company
Job Type: Full-time
Pay: RM2,400.00 - RM2,600.00 per month
Benefits:
- Free parking
- Maternity leave
Schedule:
- Monday to Friday
Supplemental Pay:
- Attendance bonus
- Overtime pay
Work Location: In person