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SHDM QC Technician QC技术员

Job Description

Responsibilities:

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

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