• 无工作经验
  • 本科
  • 招4人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 绩效奖金
  • 年终奖金
  • 专业培训
  • 免费公寓

职位描述

1. Once raw materials and components for production are received and placed in quarantine by warehouse personnel the Quality Specialist is responsible for: visual inspection, sampling, data review, and disposition based on internal policies, written procedures, and quality specifications.一旦原始物料和生产零配件经仓储人员接收且放置在隔离区后,质量专员负责:根据内部的策略文件、书面规程和质量标准进行目视检查、取样、数据审核和处置。2. Responsible for conducting inspection and disposition of any returned good such as recalls, product withdraw, complaints, and unsolicited returns. 负责对任何退货进行检查和处置,退货例如召回、产品收回、投诉和未经申请的退货。3. Maintain the Retain Sample Room inventory and conduct annual inspection and reporting维护留样室的库存情况,并进行年度检查和报告。4.Conduct inspection of critical points during production, line clearance, and collect samples according to QA sampling and inspection plans.按照QA取样和检查计划对生产过程中的关键控制点、生产线的清场、收集的样品进行检查。5.Active participation with laboratory and Warehousing the destruction of Biohazard Materials.积极参与实验室和库房的生物危害物料的销毁。6.Cooperate with other department draft material specification .配合其它部门完成质量标准的起草。7.The position is designate QP for the release of incoming/in-process product .including formulation, filling, packaging该职位被QP授权放行中控产品.含配制,灌装和包装岗位中间产品。8. Complete any other work task assigned by Incoming/in-process Supervisor.完成QA来料中控主管分配的其它工作任务 职能类别: 生物工程/生物制药

联系方式

海林市海林经济开发区东旭路7号

公司信息

公司总部位于美国加利福尼亚州圣地亚哥,生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证,配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务,符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory

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