Scientist, Quality Control 质量控制科学家(微生物/环测)
主要职责:

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; 

2. Conduct cleanroom routine environmental monitoring;

执行洁净区域的日常环境监测; 

3. Conduct plant purified water system routine monitoring;    

执行工厂纯化水系统的日常监测;

4. 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; 

5. 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;

6. All related lab activities must meet regulation    requirements, like GMP, GLP; 

所有相关的实验室行为必须符合相关法规要求,如GMP,GLP;

7. Be familiar with production test, plant  facility monitor related requirements  of regulations, like CP, USP, GMP, GB, ISO;

熟悉产品测试,厂房设施监测相关的法规,如中国药典,美国药典,良好生产操作规范,中国国家标准,国际标准组织等;

8. 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; 

9. Complete position related trainings;  

按时完成岗位相关的培训;

10. 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; 

11. 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;

12. 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; 

13. 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。

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. 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;

5. 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,可以被培训并能够和其他部门同事共同合作;

6. 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;

7. 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。

招聘人数:1
联系方式:
human_resources@fosunkitebio.com