SHDM QC Biochemist(Pudong Zhoupu)

Job Description


l  Performance in-Process, Final QC testing and stability testing of immunoassay components and assures data and test reports are valid, accurate and real.执行来料,免疫分析中间品,成品及稳定性样品的检测,确保数据及测试报告准确,真实,有效。

l  Executes quality standards in Production Quality operations and processes.严格按照质量标准执行生产质量操作。

l  Support expansion project needs, which include Test Method Transfer and validation activities.支持项目建设,包括方法转移和验证等相关工作

l  Calibration and maintenance of laboratory equipment.对实验室设备进行计量及维护。

l  Initiate and support discussions and actions with internal and external key work groups in support of  processes to release product.当内外部团队提供支持性建议及行动以确保产品放行。

l  Problem solving – has a working knowledge of available tools related to job function and incorporates the different databases, applications, personal knowledge, and individual experiences when necessary.熟悉工作中常用的问题解决工具,能够对不同的数据、应用程序、专业知识及个人经验进行整合以解决问题。

l  Initiate and drive process, and/or environment, and/or employee improvements (observe, identify, and communicate ideas to improve the day to day responsibilities and job satisfaction of the entire team).能够对流程、环境及人员管理进行改进。(能够在日常工作中发现、识别并沟通合理化建议进行改善并提高团队满意度)

l  Function as a leader within QC; be able to represent and support the interest of QC, internally and externally of the department; work with all QC supervisors/manager to identify mutual challenges and solutions.作为QC的领导;能够代表和支持部门内部和外部QC的利益;与所有QC主管/经理一起确定共同的挑战和解决方案

l  Drives innovative digital solutions to improve production quality by thinking outside of the box, coaching and fostering the application of creativity methods.通过创新思维、指导和培养创造性方法的应用,推动创新数字解决方案,以提高生产质量

l  Help to reach department goals and objectives through collaboration and influence.协助团队完成目标

l  Provide guidance and/or training to high performing technicians and new Biochemist hires as needed.对新的技术员及分析师进行指导和培训:

l  Train new biochemist for the team, including pre-fill and post-fill testing.对罐装前及灌装后产品测试进行培训

l  Provide the basics of how to approach troubleshooting.提供基础的技术支持

l  Other related projects or tasks assigned by superior or company.主管分配的其他任务。

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

Education and Experience             

l  3-6 years' experience working in a similar role in the Pharmacy/medical diagnostic/medical device, FDA-regulated laboratory industry.3-6年制药、医疗诊断、医疗器械或FDA监管的实验室相关岗位工作经验。

l  Moderate knowledge of GMP, ISO 14644,ISO13485 and 21CFR.GMP,ISO14644/13485 以及21CFR知识丰富

l  Ability to write, review, and approve quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance/OOS investigations, CAPA, and change controls associated with the laboratory.有能力阅读撰写批准相关的质量体系文件,熟悉质量体系程序SOP/TS/WI/RS/NC/OOS/CAPA并能够协助开展实验室调查

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  Bachelor’s Degree (or equivalent degree) with a discipline in Biology, Chemistry, Biochemistry, Biotechnology, Microbiology, Pharmaceutical, Molecular Biology or Medical Technology is required.生物学、化学、生化学、生物技术、微生物学、药学、分子生物学、医疗技术相关专业本科或同等学历。 

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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