工作时间：8：30-17：00（周末双休）

Position职位：QC Engineer-Elecsys 质量控制工程师-免疫产品
BA / Dept部门：Quality Control 质量控制部
Job Summary职位概述:
The job holder ensures to meet / perform
- Legal, regulatory and business framework 法律法规及业务框架
- Responsible for QC routine test including PV, commercialization and type testing.负责QC常规测试如PV，商业批和型式检验
- SCAR handling SCAR处理
- Data analysis 数据分析
- Quality issues analysis 质量问题分析
Main Tasks & Responsibilities主要工作职责 :
- Responsible for performing QC routine test including PV, commercialization and type testing inspection independently.
独立负责QC常规测试如PV，商业批和型式检验。
- Responsible for cobas e analyzer instrument check, preventive maintenance activities for designate equipment.
负责cobas e分析仪设备检查和指定设备的预防性维护工作。
- Responsible for record and maintenance documents according to related procedures.
根据相关程序负责记录和维护文件。
- Responsible for creation, update and distribution of relevant documents, including SOP and test procedure.
负责相关文件的创建，更新和分发，包括SOP和测试程序文件。
- Investigate product issues according to test procedures or equipment SOP.
根据测试程序或设备操作规范调查产品问题。
- Initiate SCAR when incoming materials has quality issues. Assist investigations by provide test results
来料有质量问题时启动SCAR。提供测试结果协助调查。
- Responsible for coordination and execution of stability stress testing
负责稳定性挑战性实验测试的协调和执行
- Responsible for training technical equipment, test procedure for QC engineers. Be familiar with equipment principles
负责对QC工程师进行技术设备、测试步骤的培训。熟悉设备原理。
- Ensure alignment with regulatory specifications, defined guidelines as well as legal specifications of work, health & environmental safety.
确保符合法规规范、明确的指导方针以及工作、健康和环境安全的法律规范。
- Assistant new employee to understand training process, qualification profiles.
协助新员工了解培训流程、资质要求。
- Support QC internal project implementation.
支持QC内部项目的实施。

Qualification & Experience任职资格:
Bachelor’s Degree or more in Chemistry or Clinical biochemistry or Biochemistry or Pharmacy or Biological Engineering
具备化学,临床生化,生化,药学或生物工程类专业本科以上学历
1 year experience in the required functional area 一年及以上相关工作经验
IVD industrial experience 体外诊断试剂行业工作经验