Job Description:
1. In charge of the preparation of reagents, calibration materials, and quality control products, strictly follow SOP, keep all records in the receipt, review, and use of raw and supplementary materials, monitor the stock condition and work with procurement team to replenish accordingly.
2. Responsible for the collection and bookkeeping of raw materials, auxiliary materials, packaging materials, etc. for production.
3. Responsible for filling in production logbook to ensure that the data is true, complete and accurate.
4. Ensure production equipment, facilities and production environment can meet production process and regulatory requirements.
5. Ensure employee working environment and quality in strict accordance with the system and regulatory requirements.
6. Strictly comply with laboratory-related operation and quality management requirements.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.
Job Requirements:
1. Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.
2. A bachelor's degree. Fresh graduates are welcome to apply.
3. Experience in IVD, controlled environment production, quality system, R&D and etc.
4. Expertise in the operation and maintenance of lab instruments and data systems.
5. Understand the relevant requirements of the production quality system for in vitro diagnostic products.
6. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
7. Familiar with IVD product development and commercialization life cycle.
8. Systematically project management, good planning, execution and timely communication. Good presentation skills.
9. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
10. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.
