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

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