1. Mainly responsible for the implementation of biological analysis and testing experiments related to our company's products, such as: ELISA,qPCR, Virus titer testing, extraction of genomic DNA, etc;
2. Responsible for implementing the validation experiments of biological analysis methodology Optimization;
3. Responsible for investigating and analyzing laboratory deviations/changes/OOS records related to the testing process, and promptly reporting any abnormal situations;
4. Responsible for daily testing and key reagents used in the production process Molecular biology related experiments in material release inspection;
5. Responsible for writing GMP documents such as SOP for molecular biology related analysis methods, management SOP, method validation or confirmation plans and reports;
6. Conduct daily laboratory activities in accordance with QC laboratory regulations and relevant regulatory requirements
7. Need to assist in completing other QC testing related work
1. Bachelor's degree or above in Pharmacy biology. Majors in basic medicine or related fields, with QC related work experience preferred;
2. Have more than two years of QC work experience, familiar with the guidance principles related to method validation, and have strong ability to consult and learn guidance principles;
3. Proficient in biological analysis methods and related experimental skills such as ELISA, qPCR, etc;
4. Strong ability to analyze and solve problems;
5. Possess good work habits, rigorous and meticulous, strong sense of responsibility;
6. Possess good English reading and writing skills