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QC-微生物高级技术员 QC-Specialist-Senior Microbiologist 面议

本科及以上 二年以上 黑龙江

更新时间: 2019-09-18

牡丹江基纳瑞克斯生物制药有限公司
外商独资 500 - 999人

职位要求

招聘日期: 2018-12-03 ~ 2019-11-29

职位描述


Sampling, testing of viable environmental monitoring samples and trending reports for all manufacturing areas


浮游菌环境监控样品和取样和检测,以及所有生产区域的趋势报告


Bio burden and endotoxin testing review and trending of on raw materials and finished products


原辅料和成品的微生物负荷和内毒素检测审核和趋势


Finished product sterility testing trending and report


成品的无菌检测趋势与报告


Water system trending reports to include chemistry testing


水系统趋势报告,包括化学测试


Follow laboratory written procedures at all times


任何时候都要遵守实验室书面规程


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


Work closely with the Quality Auditor for supplier’s reduced testing program evaluation


与质量审核员合作,为以减少的供应商测试项目进行评估


Maintain accurate records per cGMP’s and applicable international standards


按照现行的GMP和适用的国际标准维护记录


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


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


Document accurately and consistently data required on laboratory logbooks, chamber logbook 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


Coordinate laboratories self-audit program for both chemistry/microbiology laboratories


为理化和微生物两个实验室协调化验室自我审核程序


Perform other duties as assigned


完成分配的其他工作


Key individual for coordinating all laboratories trend analysis and reports


作为协调所有化验室趋势分析和报告的关键人员