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Associate Process Developer,Immunoassay

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    Location(s)
  • Jiangsu, CN

Status Regular Job ID JR-009412 Recruiting Region Asia-Pacific

参与NPI开发,负责新产品生产制程开发和验证工作,输出产品工艺规程、生产/检验作业指导书和记录等制造工艺文件;(适用于试剂工艺和仪器工艺);

Participate the NPI development, be responsible for the new product process development and validation, output the process procedure, production/inspection work insturction and related manufacturing process documents.

负责新产品转产验证批次的准备、培训、组织和分析工作,并输出相关验证报告;(适用于试剂工艺和仪器工艺);

Be responsible for the new product  transferring prepration, training, arrangement and analysis, and output the relevant validation report.

负责在线产品生产过程的技术支持,客户投诉和生产偏差问题的分析,解决相关工艺技术问题,维护生产工艺文件满足产品质量要求;(适用于试剂工艺和仪器工艺);

Be responsible for the onsite technical support, customer complain, production deviation analysis, solve the related process technical issues, and maintain the process documents to meet the quality requirement.

负责协调策划产品设计变更和/或工艺变更的导入、执行和跟踪变更的实施(适用于试剂工艺和仪器工艺);

Be responsible for the product design change and/or process change, introduce, implement and follow up the implementation.

负责试剂产品质控品&工作校准品的计划、制备、库存维护、稳定性监控;(适用于试剂工艺);

Be responsible for the reagent product quality control and calibration planning, preparation, inventory maintenance, stability monitoring.

主管分配的其他任务。

Any tasks assigned by supervisor.

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