1.Mainly responsible for the implementation of bioanalytical assays for our products, such as ELISA, qPCR, virus titer assay, genomic DNA extraction, etc.
2.Responsible for the implementation of bioanalytical methodological validation experiments. Optimization.
3.Responsible for the investigation and analysis of laboratory deviations/changes/OOS records related to the testing process and timely reporting of abnormalities.
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 SOPs for molecular biology-related analytical methods, management SOPs, method verification or validation protocols and reports.
6.Perform daily laboratory activities in accordance with QC laboratory regulations and relevant regulatory requirements.
7.Required to assist in other QC testing-related work.
1.Bachelor's degree or above, in pharmacy, Biology, Basic medicine and other majors, QC-related work experience is preferred.
2.More than two years of QC work experience, familiar with method validation-related guidelines, with a strong ability to review and learn the guidelines.
3.Proficiency in bioanalytical methods and other related testing skills such as ELISA, qPCR, etc.
4.Strong analytical and problem-solving skills.
5.Have good working habits, rigorous and meticulous, strong sense of responsibility.
6.Have good English reading and writing skills.