职责描述：1.Develop, implement quality system improvement and evaluate its effectiveness. Ensure human errors are corrected. Determine if the human errors are systemic problem. The expectation is fewer than 10% of all exception reports being attributed to human error. Use DMAIC (Define Measure Analyze Improve Control) process and skills to diagnose and prevent/solve product design and manufacturing process issues.
开发并实施质量管理体系改进，并评估其有效性。确保人的错误得到纠正。确定是否人为错误是系统问题。期望是所有异常报告少于10％归因于人的错误。使用DMAIC（定义测量分析改进控制）工艺和技能，诊断和预防/解决产品设计和制造工艺问题。
2.Provide analytical investigations and develop key performance indicators as deemed appropriate to measure the quality of the product and/or services; the efficiency of the operations, for example turnaround times for completion of OOSs, OOTs, IRs, CAPAs, Complaint investigations, APRs, CRs, DCRs, etc.
提供分析调查和开发认为适于产品和/或服务的质量度量的关键绩效指标,运营效率,例如OOSs、OOTs、IRs、CAPA、投诉调查、年度质量回顾、CRs、DCRs等等周转时间。
3.Review documentation for completeness and accuracy, Analyze data in support of Right First Time Metric for all documents including attention on complete, accurate documents first time, companywide and generate summary reports.
审核文件的完整性和准确性,分析数据以支持所有文件首次正确原则，包括注意全公司首次文件完整、准确,并生成总结报告。
4.Create written documentation in accordance with USFDA and Chinese cGMP requirements to support product development and manufacturing.
创建符合美国cGMP和中国GMP法规的书面文件以支持产品开发和生产
5.Other tasks assigned by superior
领导安排的其他其他任务

职位要求：
1. Industry experience within a QA/QC department at a FDA-Regulated, Pharmaceutical or other regulated industry. 在遵循FDA法规、制药或其他规定行业QA/QC部门经验
2. Master or Bachelor's degree plus more than 5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
硕士或学士学位，至少5年相关工作经验，能很好地理解的规定的职能范围,或同等教育和工作经验。
3. Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), Word, Excel, power point and Project.
生产工艺知识和相关统计技术（六西格玛、统计过程控制），Microsoft
4. Demonstrated ability to perform multiple tasks and ability to effectively manage conflict.
能够执行多个任务，具有能有效控制冲突的能力。
5. Ability to work well in a team and be able to communicate effectively with colleagues, customers and external clients.
团队中有好的工作能力，能够和同事、客户以及外部委托方有效沟通。
6. Professionalism, Ethical, Compliance Mindset 专业精神，道德和合规理念

Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products.
爱美津制药是一家集研发和制造于一体的跨国公司，旨在向美国提供高质量的仿制药品。
With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service.
凭借在美国和海外的制药资产和技术专家队伍，爱美津致力于提供高品质产品、有竞争力的价格和无以匹敌的客户服务。
At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd.
2007年底，爱美津完成了在中国苏州工业园区的口服固体制剂生产厂的收购，并成立了苏州爱美津制药有限公司。
苏州爱美津制药的里程碑如下：
2007 苏州爱美津成立
2008 首次获得美国法规文件受理
2009 首次美国食品药品监督管理局上市批准和常规检查
2010 获得美国食品药品监督管理局的批准生产大包装片剂
2012 通过中国食品药品监督管理局再次检查-新版GMP (2010版)
2013 通过美国食品药品监督管理局检查- 4个简化新药被推荐批准
2014 产品在美国市场上市, 中国市场产品恢复生产。
2015 通过美国食品药品监督管理局针对数据完整性的专项检查