检测科学家(原辅料/包材)QC Scientist

职责描述：
1. Conduct related daily testing and test method development, such asendotoxin testing, TOC, Conductivity test，HPLC test
执行日常的相关测试和检测方法的开发，如细菌内毒素检测，总有机碳，电导率测试，HPLC 测试等。
2. Prepare test reports to support raw material/ product/ plant facilityand 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。
3. Responsible for out test of raw material, package material
负责原辅料包材相关的外部测试。
4. Follow new project and strategy, develop the new analysis methods and technology.
结合公司项目从事新的检测方法和技术的开发工作。
5. Support to conduct cleanroom routine environmental monitoring.
协助执行洁净区域的日常环境监测。
6. Draft all QC related SOPs, including test SOP, management SOP, andupdate these SOPs basing on the validation results or trend assayresults 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 。
7. Order and maintain the consumables and reagents used in QC testing.
采购并管理测试所需的试剂耗材。
8. Operate QC equipment, cooperate with relevant departments to conductthe 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。
9. Cooperate with other department to conduct related validations, draftprotocols, perform the procedures, analyze and report the results.Participate in related deviation/OOS investigations. Timely review theabnormal 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。
10. Perform all company business in accordance with relevantregulations, company policy and procedures.
按照公司正常规定及相关法规等进行所有的公司事务。
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。


任职要求：
1. BS degree BS degree in biochemistry, chemistry or a relateddiscipline with 2-3 years of QC relevant experience invaccine/bio-pharmaceutical industry, or MS in related discipline with atleast one years of relevant work experience.
生物化学、化学或其他相关领域学士或硕士学位，3~5年疫苗、生物制药、无菌化药（如大输液）等行业QC相关工作经验。
2. Knowledge of standard requirements for raw material, packagematerial, product testing as stated by GB, CP, GMP.
具有国标、中国药典和GMP等法规关于原辅料包材成品等检测知识。
3. Familiar with related test equipment, like PTS, pH, HPLC, UV, FTIR, HPLC
熟悉相应的测试仪器设备，如PTS、pH计、紫外、红外、气相色谱等。
4. Working knowledge and hands-on technical skills of lab/third party oftest operations and testing methods in relevant industry, such asendotoxin testing, TOC, Conductivity test, identification.
有相关工业领域实验室或者第三方检测机构实操经验，如细菌内毒素检测，总有机碳，电导率测试，鉴别。
5. Could do assay develop, analysis method validation. If the candidatehas relevant experience, it is an advantage
有能力进行检测方法的开发验证。有相关经验者优先。
6. Ability to analyze data, troubleshoot, train and work closely withother 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。
7. Ability to work effectively in QC team. Good written, interpersonaland 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。