l Perform incoming inspection, In-Process, final QC testing and stability testing of immunoassay components, ensure the test data be recorded accurately and timely.执行来料，免疫分析中间品，成品及稳定性样品的检测，确保检测数据准确及时记录?
l Calibration and maintenance of laboratory equipment.对实验室设备进行校验及维护?
l Perform sampling for water system and stability sample.实施水系统取样及稳定性样品取样?
l Perform retention sample inpection.执行留样的检查?
l Supports in setting up new test equipment and measurement tools.支持建立新的测试设备及测量工具?
l Assist to perform OOS investigation.协助完成OOS 调查?.
l Assist to perform routine environment monitor and water testing.协助执行洁净区域的日常环境监测及工艺用水检测?
l Comply with GMP laboratory guideline.遵循GMP实验室准则?
l Comply with safety guidelines.遵守安全准则?
l Help to reach department goals and objectives through collaboration and influence.协助团队完成目标?
l Initiates escalations in case of failures to the cross functional teams.主动上报异常情况?
l Supports innovative digital solutions to improve quality by thinking out side of the box.支持创新的数字解决方案，通过创新思维提供质量?
l Finish other tasks assigned by supervisor/manager.完成上级领导安排的其他工作
Education and Experience
l At least 2 years’ experience working in a similar role in the medical diagnostic/medical device/Pharmaceutical, FDA-regulated laboratory industry.至少2年以上医疗诊断、医疗器械、药品或FDA监管的实验室等相关岗位工作经验
l Knowledge of GMP, ISO 13485.具备GMP,ISO13485 相关知识
l Prior experience manufacturing commercialized automated immunoassays and/or ELISA and chemiluminescent products is preferred.免疫分析、酶联免疫吸附分析及化学发光分析产品工作经验优先
l College’s Degree (or equivalent degree) with a discipline in Biology, Chemistry, Biochemistry, Biotechnology, Microbiology, Molecular Biology,Pharmacy or Medical Technology is required. Advanced degrees may be substituted for experience, where applicable and vise versa.生物学、化学、生化学、生物技术、微生物学、分子生物学、药学、医疗技术相关专业大专或同等学历。
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time