1、Perform sample management, including sample receiving, registration, storage, distribution, destruction, etc.
执行样品管理工作，包括：样品接收、登记、储存、分发、销毁等。
2、Perform sample record and test report management, including application, distribution, collection and issuance of test report, etc.
执行样品记录及检验报告管理工作，包括：检验记录申请、分发、收集、出具检验报告等。
3、Perform stability sample management, including: drafting stability plan, storing, sampling and distributing stability samples, sorting out stability data, drafting stability reports, etc.
执行稳定性样品管理工作，包括：起草稳定性方案起，稳定性样品储存、取样、发放，整理稳定性数据，起草稳定性报告等。
4、Perform reagent consumable management and instrument and equipment management.
执行试剂耗材管理及仪器设备管理工作。
5、By assisting system leader to conduct GMP Self-Inspection, and executive the implementation action to maintain the level of GMP compliance.
协助体系负责人实施GMP自查，执行改进措施，维持GMP符合性水平。
6、By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory.
通过维护质量体系和文件系统，确保质量控制部的质量运作体系符合法规要求。
7、Report abnormal events to the supervisor with initiative and in time.
及时主动地向上级报告异常事件。
· By reporting abnormal events during operation processing at *** time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.
运营过程中发现的异常事件应在***时间向上级报告详细数据和信息，以提示上级进行调查并及时正确的解决问题。
· By involving the investigation, provide actual data and information to helping to prevent the same issue happened repeatedly.
参与调查过程，提供真实的数据和信息，以帮助避免类似问题重复出现。
· By providing technical support within the team, if necessary, share knowledge and experience within working section.
需要时向团队内提供技术支持，分享工作领域内的知识和经验
8、Stick lab safety regulations to prevent occurrence of accident.
严格遵守实验室安全规定，防止意外事故发生。
· By obey the safety requirements for storage, usage and disposal of reagents, hazardous chemicals and waste.
遵守试剂、危化品和废弃物的存储、使用和处理安全要求。
· By following the usage requirements of facilities of water, electricity, gas and etc. in lab.
遵守实验室内对水、电、气等公用设施的使用要求。
· By clearing the working space in time and patrol working section at the end of working day to secure the safety of lab.
工作日结束后，及时清理工作空间，检查相关工作区域，确保实验室安全。

1、Knowledge and understanding of regulatory requirement (NMPA, USFDA and EMA etc.) within QC areas.
了解QC领域内的监管要求（NMPA、USFDA和EMA等）。
2、Practical experience in QC owned processes such as OOS/OOT, trending etc.
拥有QC相关流程的实践经验，如OOS/OOT、趋势分析等。
3、Experience in LIMS system management, sample management, document management, reagent consumables management, instrument and equipment management in GMP QC laboratory.
在GMP QC实验室下，具有LIMS系统管理、样品管理、文件管理、试剂耗材管理、仪器设备管理的经验。
4、Supporting investigation of production-related issues.
支持对生产相关问题的调查。

1、QC related experience in (bio)pharmaceutical industry, good knowledge of cGMP related to pharmaceutical industry and expert knowledge of laboratory safety.
具备（生物）制药行业QC相关工作经验，良好的制药行业相关的cGMP 知识和专业的实验室安全知识。
2、Expertise in QC assays, including pharmacopeial common assays and method validation / verification.
熟悉QC检测领域专业知识，包括药典通用检测方法以及方法验证/确认。
3、Able to access professional materials in English and compile quality system documents in Chinese and English.
能查阅英文专业资料，并能用中英文编撰质量体系文件。
4、Six Sigma and / or Lean experience is preferred.
6西格玛和/或精益经验者优先。

College degree or above, major in biopharmaceutical, pharmacy, biotechnology or related.
大专及以上学历，生物制药、药学、生物技术或相关专业。