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职责描述:
Conduct related daily testing and test method development, such as PCR, Flow cytometry, ELISA, Western blot etc.
执行日常的相关测试和检测方法的开发,如PCR检测, 流式细胞术、酶联免疫吸附试验, 蛋白质印迹测试。
Prepare test reports to support raw material/ product/ plant facility and other related material release.
准备支持原料、产品、厂房设施以及其他相关物料放行的相关报告。
Follow new project and strategy, develop the new analysis methods and technology.
结合公司项目从事新的检测方法和技术的开发工作。
All related lab activities must meet regulation requirements, like GMP, GLP.
所有相关的实验室行为必须符合相关法规要求,如GMP,GLP
Draft all QC related SOPs, including test SOP, management SOP, and update these SOPs basing on the validation results or trend assay results or regulation.
编写所有QC 相关的SOP,包括测试SOP,管理SOP,并根据验证结果或者趋势分析结果或法规及时更新相关SOP
Complete position related trainings.
按时完成岗位相关的培训
Operate QC equipment, cooperate with relevant departments to conduct the equipment calibration and maintenance timely.
使用QC相关仪器,和相关部门合作及时实施仪器的校验和维护
Cooperate with other department to conduct related validations, draft protocols, perform the procedures, analyze and report the results. Participate in related deviation/OOS investigations. Timely review the abnormal cases.
和其他部门合作进行相关的验证工作,编制方案,实施检测,分析并汇报结果。参与相关的偏差/OOS调查。及时回顾异常情况。
任职要求:
Master or Ph.D. degree in immunology, molecular/cell biology.
免疫学、分子生物学或细胞生物学或其他相关领域硕士或博士学位。
Familiar with immunology and/or molecular biology methods, such as PCR, Flow cytometry, ELISA, Western blot etc.
熟悉免疫学、分子生物学、细胞生物学相关技术方法,如PCR、流式细胞术、ELISA、蛋白免疫印迹。
Ability to analyze data, troubleshoot, train and work closely with other function
具有数据分析、异常结果原因分析的能力,并可参与跨部门合作。
Good written, interpersonal and communication skills required.
良好的写作、团队合作及沟通技巧。