职位描述
1. Culture and observation of viable environmental monitoring samples.对环境监控样品进行培养和观察。2.Communicate viable environmental monitoring data to the Manufacturing Department and QA.及时将环境监控数据反馈给生产部门及QA。3.Maintain the environmental monitoring and records related to Micro-Lab.维护微生物实验室相关环境监控及记录。4.Responsible for environment monitoring of sterility test room (226) and isolator of dust particles and settling plates to ensure the clean room meets the pre-defined requirements of environmental monitoring.负责无菌检查室（226）及隔离器的尘埃粒子和沉降菌等微生物环境监控，保证洁净室（区）符合预定的环境监测要求。5.Perform identification testing classification of microorganisms implemented in the facility.执行厂房实施中发现的微生物的鉴定。6.Maintain the microorganisms record for the facility维护菌种鉴定记录。7. Bioburden and endotoxin testing on raw materials and Excipients.原辅料和包装材料的微生物负荷和内毒素检测。8.Sterility testing, Particulate Matter and endotoxin test on finished product.成品的无菌检测、不溶性微粒检测以及内毒素检测。9. Water testing and report.水检验和报告。10. Follow laboratory written procedures at all times.任何时候都要遵守实验室书面规程。11. Provide support to manufacturing operations during media fills.培养基模拟灌装期间为生产操作提供支持。12. Conduct culture media growth promotion test, and monitoring.进行培养基的促生长检测和监控。13. Maintain accurate records per cGMP's and applicable international standards.按照现行GMP和适用的国际标准维护记录。14. Comply with cGMP and applicable international standards and regulations and safety procedures.遵守现行GMP和适用的国际标准和法规以及安全规程。15. Comply with established Quality Management System procedures and company policies.遵守已建立的质量管理系统规程和公司策略。16. Document accurately and consistently data required on laboratory logbooks, chamber logbooks, and reporting forms.将需要的数据准确且一致的记录在实验室日志、仪器日志和报告表格中。17. Participate in the laboratory self-audit program.参与实验室内审程序。18. Participate in the drafting and updating related to Micro-lab documents.参与微生物实验室相关文件的起草、修改等工作。19. Confirm the qualification for the supplier and material of the consumables and maintain inventory and purchase plan.对所需培养基、消耗品的供应商及物料进行资质确认，维护库存及提报计划。20. Perform other duties as assigned.完成分配的其它工作 职能类别： 化学分析测试员
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
1年经验 
本科 
招3人 
01-02 发布
