QC support Professional works as a team member of QC Process support team. They will have a thorough knowledge of the key analytical process in the department to fully support operational teams. The daily work is including but not limited to DV, CR, validation, finding, PC, lab system set up, QC 4.0, periodic document, such as APR, QMR, problem solving, OOS investigation, SOP writing and training, implement methods of analysis and signals, etc.
质量控制支持专员是质量控制工艺支持团队的成员。他们将对部门的关键分析流程有透彻的了解，为检测团队提供全面支持。日常工作包括但不限于 DV、CR、验证、审计发现项处理、PC、实验室系统设置、QC 4.0、文件（如 APR、QMR）、问题解决、OOS 调查、SOP 编写和培训、实施分析方法和Signals等。

Main Job Tasks 主要工作任务:

• Process design, set up methods of analysis and execute method transfer studies and ensure process compliance 流程设计，建立分析方法并进行方法转移研究， 确保流程符合性
• SME on sampling or testing. 取样或检测流程专家或流程负责人
• Head and document laboratory investigation as LI supervisor role作为实验室调查主导者，主导和记录实验室调查
• Perform problem solving related to testing of device, products, API, excipients and water for pharmaceutical use on reruns, deviations etc. in test operation teams. and support cross Dept. problem solving 解决检测实验室发生的与器械，产品，API, 辅料及制药用水检测相关的再测试，偏差等问题并支持跨部门的问题解决
• Has ability to write methods of analysis and other operational documents and translate documents from English into Chinese. 具备书写分析方法和其它操作文件的能力，并翻译成英文
• Prepare for the audit and inspection and to be a auditee to answer the questions and be the finding owner to investigate and close the finding. 准备内外审计并作为被审员回答问题，并且也作为发现项的负责人，调查和关闭发现项
• LIMS superuser or template builder 系统超级用户或模板建立
• Implement QC 4.0 projects in local sites. 在STJ实施 QC 4.0 项目。
• Perform PC and continuous improvement on QC process 对QC流程进行现场确认和持续改进
• Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write methods of analysis and other operational documents, translate key operational documents from English into Chinese. 所有操作和记录文件符合GMP、工厂和公司流程政策。编写分析方法和其他操作文件，将关键操作文件的英文版本翻译成中文。
• Be familiar with general requirements in Pharmacopeia; Prepare analytical procedure according to Pharmacopeia; Identify the gap of local procedure and Pharmacopeia; Deep understanding of guidelines of Pharmacopeia. 熟悉药典通用要求；可以按照药典编撰分析方法；分析现有分析方法和药典之间的差异；深入了解药典的指导方针。
• Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations 维护安全工作环境并按照所有NN和中国安全和环境的要求工作
Professional Experience专业经验:
• Minimum 4 years of pharmaceutical QC Lab experience.至少4年制药厂质量控制实验室经验
• Previous experience with analysis and validation of medical device, water, excipients and API for pharmaceutical use desirable.具有医疗器械、制药用水及药用辅料， API分析验证的工作经验
• Preference to have LIMS experience for template building and GMP/ ISO9001/ ISO13485 regulated industry.具有LIMS模板创建经验，GMP/ISO9001/ISO13485

Education Background: 教育背景

• 4-yr (BS) D Degree in Microbiology, biology, Chemistry, Pharmacy, Engineering, Physical sciences or related field. 微生物、生物、化学、药剂学、工程学、物理科学或其他相关领域学科 4 年本科教育学士学位
• Fluent in written and spoken English 良好的英语书写和沟通能力