质量控制理化分析员

61 Responsible for the physical and chemical testing of samples for ongoing projects (including but not limited to SEC, CE-SDS and CEX, etc.).

负责在研项目的样品理化检测（包括但不限于SEC、CE-SDS和CEX等）；

61 Responsible for the transfer and validation of physical and chemical analytical methods (including but not limited to SEC, CE-SDS and CEX, etc.) for projects under development

负责在研项目的理化分析方法（包括但不限于SEC、CE-SDS和CEX等）的转移和验证；

61 Contribute to the review of SOPs. Prepare and/or revise SOPs as necessary.

参与SOP的评审；根据需要准备和/或修订SOP

Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data

负责记录、计算、汇编、解释、审查和输入数据

Responsible for the inventory management of all media, and reagents used in QC testing

负责QC测试中使用的所有介质和试剂的库存管理

61 Responsible for quality department physical and chemical analysis related experimental data analysis, project summary and reporting, a

负责质量部门理化分析相关实验数据分析、项目总结及汇报。

61 Responsible for changes, reporting OOS or deviations and assisting with investigations.

负责变更、上报OOS或偏差并协助调查。

Safety and environment 现场安全和环境合规

61 Take part in the site safety through promotion of safe workplace and personal action.

通过宣传安全的工作场所和个人行为，参与到工作现场的安全中。

61 Adhere to the Company’s safety and environmental protection procedures.

遵守公司的安全环保程序。

Quality Assurance 质量要求

61 Comply with the Company Quality Management System.

遵守公司制定的质量管理体系。

61 Author new, review and revise documents as required

按照要求撰写，审核和修改文件

General 常规要求

61 Other reasonably duties as requested by Company Senior Management from time to time.

完成领导提出的其他任务

Qualifications 任职资格

61 BSc (preferably Biology or Chemistry) or related life sciences degree

理学士（***是生物学或化学）或相关的生命科学学位.

Essential Experience必要经验

61 Minimum 2 years of relevant experience in a cGMP QC operations for Analyst;.

在cGMP质量控制操作方面至少有2年分析员的的相关经验；

61 Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing.

熟悉文献检索及相关信息检查，熟悉IND备案；

61 Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

熟练使用Microsoft Office办公软件 (Word、Excel、Powerpoint、Project、Outlook)

Preferred Experience优先考虑

61 Expert knowledge of Good Manufacturing Practice of China, EU, and USA related to Quality Management Systems and Quality Control;

具有中国、欧盟和美国质量管理体系和质量控制方面的良好制造规范的专业知识;

61 Sound understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities;

了解中国、美国和欧盟在生物制品和关键用途方面的药典差异;

61 Formal root-cause analysis training.

严谨的问题分析能力

61 Advanced computer system skills including Unicorn, Empower, and DoE and statistical analysis.

高级的计算机系统能力，包括Unicorn, Empower, and DoE和统计学分析。

关键字：

理化分析

ce_sds

cex

physical

documenting

输入数据

sec