南京招聘

Accountbilities岗位描述：

1. 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
2. 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。
3. Conduct cleanroom routine environmental monitoring 执行洁净区域的日常环境监测
4. Conduct plant purified water system routine monitoring 执行工厂纯化水系统的日常监测
5. 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。
6. 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。
7. 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 
8. 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
9. 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
10. 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。
11. 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：

1. 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。
2. 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。
3. 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。
4. 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。
5. 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。
6. 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。

关于复星凯特生物科技有限公司
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma（吉利德旗下公司）的合营企业， 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合，复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化，造福中国患者。

About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.