main responsibilities主要职责:
1、 Responsible for the test of raw materials, excipient materials, packaging materials, finished products (solution, emulsion and suspension, etc.), stability and other samples, and writing the test records.
负责原料、辅料、包装材料、成品（溶液、乳剂和悬浮液等形式）、稳定性等样品的检验，填写检测记录。
2、 Responsible for routine physical and chemical test, including but not limited to: character (appearance, etc.), identification (chemical method, UV/IR spectroscopy, etc.), assay determination (titration method, UV-HPLC, etc.), water determination (weight loss, Karl Fischer method), pH value, osmolality, density, viscosity, etc.
负责常规理化项目检测，包括但不限于：性状（外观等），鉴别试验（化学法、紫外/红外光谱等），含量测定（滴定法、UV-HPLC等），水分测定（干燥失重、卡尔费休法），pH值、渗透压、密度、黏度等。
3、 Draft URS, qualification protocol and report of laboratory instruments.
起草实验室仪器设备的URS和仪器确认的方案报告。
4、 Draft detail operating procedures for tests制定检验的详细操作规程。
5、 Instrument operation and maintenance: skilled operation and maintenance of physical and chemical laboratory instruments (such as HPLC, GC, UV spectrophotometer, balance, pH meter, dissolution instrument, disintegration instrument, etc.). Instrument daily calibration, operation qualification and performance qualification (OQ /PQ) and daily maintenance are carried out periodically. Timely report abnormal situation of instruments and deal with troubleshooting.
仪器操作与维护: 熟练操作和维护理化实验室仪器设备（如HPLC、GC、UV分光光度计、天平、pH计、溶出仪、崩解仪等）。定期进行仪器日常校准、运行性能确认(OQ /PQ)及日常维护。及时报告仪器异常情况并协助故障排查。
6、 Be familiar with the investigation process of OOS/OOT/AD, and participate in the investigation of abnormal conditions.
熟悉OOS/OOT/AD的调查流程，参与异常状况调查。
7、 Draft the verification/validation protocol of analytical methods, execute the verification/validation, and complete the report.
起草分析方法验证/确认的方案，执行验证/确认，并完成报告。
8、 Participate in the development and improvement of pilot scale production process.参与开发和改进中试规模生产的流程。
9、 Participated in the creation and improvement of validation analysis methods.参与创建和改进验证分析方法。
10、 Other work arranged by the leader领导安排的其他工作
job requirement任职条件:
1、 Education: Bachelor degree or above in science or engineering with major in chemistry, biochemistry, pharmacy, biological engineering, etc.
学历: 化学、生物化学、制药、生物工程等专业的理科或工科本科或以上学历。
2、 Familiar with FDA and Chinese Good Manufacturing Practice (GMP and cGMP) requirements熟悉FDA及中国药品生产质量管理规范的要求 (GMP及cGMP)
3、 Master HPLC, GC, IR, UV, Karl fisher and other instruments and equipment, and be familiar with the basic requirements of FDA testing, such as system applicability, requirements of injection sequence, and requirements of audit trail.掌握HPLC、GC、IR、UV、Karl fisher等多种仪器设备,熟悉FDA检测方面的基本要求，如系统适用性，进样序列的要求，审计追踪的要求。
3、Work experience: MORE than 2 years experience in QC analytical method development and drug testing in clinical or commercial stage of drugs.工作经验:2年以上药品临床阶段或商业化阶段QC分析方法开发及药品检测工作经验。
4、English level: able to read and understand professional English terms, USP, and draft bilingual SOP in writing.
英语水平: 能够阅读理解专业英语术语，USP，并能书面起草双语SOP。
Prioritized knowledge, skills and ability:优先考虑的知识、技能和能力：
1、 familiar with HPLC-MS, GC-MS, can analyze the impurity spectrum is preferred.熟悉HPLC-MS， GC-MS，能分析杂质谱的人员优先考虑。
2、 Priority should be given to those who have participated in registration audit.参与过注册核查的人员优先考虑。