SHDM QC Biochemist

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.




We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?






Your tasks and responsibilities:


  • Performance incoming inspection,  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。

  • 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。

  • 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

  • Calibration and maintenance of laboratory equipment

  • 对实验室设备进行计量及维护。

  • Initiate and support discussions and actions with internal and external key work groups in support of  processes to release product

  • 为内外部团队提供支持性建议及行动以确保产品放行。

  • 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)

  • Help to reach department goals and objectives through collaboration and influence

  • 协助团队完成目标.

  • 完成上级领导安排的其他工作

Finish other tasks assigned by supervisor/manager




Your qualifications and experience:


  • At least 3 years’ experience working in a similar role in the Pharmacy/medical diagnostic/medical device, FDA-regulated laboratory industry.


  • Moderate knowledge of GMP, ISO 17025,ISO13485 and 21CFR

具备GMP,ISO17025/13485 以及21CFR知识

  • Ability to write and review 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


  • Prior experience manufacturing commercialized automated immunoassays and/or ELISA and chemiluminescent products is preferred.





Our global team:


Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.


Our culture:


Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.


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As an equal opportunity employer, we welcome applications from individuals with disabilities. <use your country EEO required language where applicable>


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We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. 


To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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