QC Scientist- 质量控制科学家(微生物/环测)
复星凯特生物科技有限公司ShanghaiUpdate time: May 14,2019
Job Description
Accountbilities岗位描述:
- Conduct related daily testing and test method development, such as microbe limit testing, sterility testing, endotoxin testing, TOC, Conductivity test 执行日常的相关测试和检测方法的开发,如微生物限度检测,无菌检测,细菌内毒素检测,总有机碳,电导率测试
- Be familiar with regular microbiological basic testing methods, such as media/dilution preparation, media growth promotion testing, Gram staining, bacterial strain management. 熟悉相关微生物基本检测方法,如培养基配制、稀释,培养基促生长检测,革兰氏染色,菌种管理等。
- Conduct cleanroom routine environmental monitoring 执行洁净区域的日常环境监测
- Conduct plant purified water system routine monitoring 执行工厂纯化水系统的日常监测
- Familiar with related test equipment, like sterility testing system, endotoxin test system, , airborne microbe sampler, airborne particle sampler, autoclave and so on 熟悉相应的测试仪器设备,如无菌检测系统,细菌内毒素测试系统,浮游菌采样器,粒子采样器,灭菌设备。
- Prepare test reports to support raw material/ product/ plant facility and other related material release. 准备支持原料、产品、厂房设施以及其他相关物料放行的相关报告。
- Draft all QC related SOPs, including test SOP, management SOP, and update these SOPs basing on the validation results or trend assay results or regulation. 编写所有QC 相关的SOP,包括测试SOP,管理SOP,并根据验证结果或者趋势分析结果或法规及时更新相关SOP
- Order and maintain the consumables and reagents used in QC testing. 采购并管理环境监测所需的试剂耗材
- Operate QC equipment, cooperate with relevant departments to conduct the equipment calibration and maintenance timely. 使用QC相关仪器,和相关部门合作及时实施仪器的校验和维护
- Cooperate with other department to conduct related validations, draft protocols, perform the procedures, analyze and report the results. Participate in related deviation/OOS investigations. Timely review the abnormal cases. 和其他部门合作进行相关的验证工作,编制方案,实施检测,分析并汇报结果。参与相关的偏差/OOS调查。及时回顾异常情况。
- Assist QC manager to complete other work if needed. 如需要协助QC经理完成其他相关工作
Qualifications任职要求:
- BS degree in biochemistry, microbiology, immunology, molecular/cell biology or a related discipline with 2-3 years of QC relevant experience in vaccine/bio-pharmaceutical/nutrition industry, or MS in related discipline with at least one years of relevant work experience. 生物化学、微生物学、分子、细胞生物或其他相关领域学士学位,2-3年疫苗、生物制药或营养品等行 业QC相关工作经验;或者相关领域硕士学位,至少1年相关工作经验。
- Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, GMP. 具有国标、中国药典和GMP等法规关于厂房设施监测和基本生物检测知识。
- Working knowledge and hands-on technical skills of lab/ Environmental monitoring operations and testing methods in relevant industry, , such as microbe limit testing, sterility testing, endotoxin testing, TOC, Conductivity test 有相关工业领域实验室或者环境监测实操经验,如微生物限度检测,无菌检测,细菌内毒素检测,总有机碳,电导率测试。
- Ability to analyze data, troubleshoot, train and work closely with other function 具有数据分析、异常结果原因分析的能力。
- Ability to work effectively in QC team. Good written, interpersonal and communication skills required. 具有在QC团队高效工作的能力。良好的写作、团队合作及沟通技巧。
- Good communication skills in English and Chinese, fluent in speaking, writing and reading in both languages.
良好的英语和中文沟通能力,能流利地说、写、读这两种语言。
职能类别: 质量管理/测试工程师(QA/QC工程师)
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上班地址:康南路222号
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