Quality Control Manager / Quality Control Officer

Responsibilities:

1. Review and enhance protocols and associated GMP documentation related to QC.
2. Analysis of raw material, in-process and final bulk cell therapy / gene product samples according to Standard Operating Procedures (SOP) and test methods.
3. Perform quality control tests: one or more of the following analytical techniques: flow cytometry, blood culture test, cell culture, sterility test, mycoplasma test, and tests specific to cell-based products.
4. Perform qualification, maintenance and calibration of QC equipment and instrument.
5. Review and enhance quality control workflow.
6. Other duties as assigned by the supervisor or management team.

Qualification and requirements:

1. Bachelor degree in biotechnology, biomedical engineering, medical laboratory science, and other similar disciplines with at least 2 years relevant working experience in PIC/S GMP quality control is essential, 1-2 years at managerial or supervisory level for Manager position and less experience for Officer role; or
2. Postgraduate degree of science relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other similar sciences with at least 1-2 years of working experience at managerial or supervisory level in GMP manufacturing or quality control of ATPs;
   
3. Preferably with practical experience in PIC/S GMP QC testing of sterile products (including cell therapy products) e.g., sterility test, endotoxin test, mycoplasma test, and specific tests to cell-based products .
4. Proficiency in English and Chinese, and computer skills.
5. Excellent communication, problem-solving skills and time management.
6. Self-motivated and a good team player.

We offer 5.5-day/flexible 5-day work with good career prospects and excellent fringe benefits to the right candidates.

Interested person please send your full resume with your current and expected salary and date of availability to the Human Resources Department.