Job responsibility 工作职责
Laboratory equipment 实验室仪器设备
61 Manage and perform and/or support equipment and QC support systems, ensure the lab is in clean status;
管理、执行以及/或支持仪器设备和QC辅助系统,确保实验室处于整洁有序的状态；
61 Ensure calibration and maintenance is within expiration date basing before use;
确保仪器在使用前其计量和/或维护在有限期内；
61 Initiate, review and revise related equipment operation procedure.
起草、审核和更新 相关仪器的操作流程。
Testing 检验
61 Conduct compendial method: ID testing, physical and chemical test, bacterial endotoxin and microbial limit testing;
执行药典常规方法：鉴别测试、理化测试、细菌内毒素和微生物限度测试；
61 Be familiar with basic testing methods of raw material;
熟悉相关原辅料基本检测方法；
61 Initiator and review methods and procedures for completeness and accuracy;
起草方法操作规程和其他管理规程，审核其完整性和准确性；
61 Good time management skills to ensure smooth implementation of projects.
具有很好时间管理能力，以确保项目的顺利实施。
Data Management 数据管理
61 Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;
对记录、计算、编辑、解释、审核以及录入数据负责；
61 According to different pharmacopeia, do gap assessment for material.
依据不同的药典，对物料进行差距分析。
General 常规要求
61 Comply with general Company Policies and Procedures.
遵守公司政策和程序；
61 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
Safety and environment 现场安全和环境合规
61 Promote a culture of safety work place through personal actions;
以身作则推动建立安全的工作环境；
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序
Quality Assurance 质量要求
61 Comply with the Company Quality Management Systems;
遵守公司质量管理体系;
61 Initiate new and revise documents, participate in investigation teams, and provide input to quality systems (change control, CAPA, deviations, OOS and Risk assessment, etc.);
起草新文件和修订文件，参与调查团队并且在质量体系运营中（变更、CAPA、偏差、OOS和风险评估等 ）提供支持；
61 Comply with GLP and cGMP, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.
遵守GLP和cGMP的要求，包括但不限于：培训记录、实验室记录、书面规程、仪器设备监控系统和实验室工作日志的维护。

Qualifications 任职资格
61 BS degree in Chemistry, Biochemistry, Microbiology, Molecular/cell biology or a related discipline;
化学、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；
61 Minimum 3 years of QC relevant experience in Anti-body/Bio-pharmaceutical/Vaccine industry;
至少3年抗体、生物制药或疫苗等行业QC相关工作经验；
61 Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, USP, EP, cGMP;
具有国标、中国药典、美国药典、欧洲药典和cGMP等法规关于生物药品检测知识；
61 Working knowledge and hands-on test experience in relevant industry;
有相关工业领域工作知识和检测实操经验；
61 Working knowledge and hands-on Ability to analyze data, troubleshoot;
具有数据分析、异常结果原因分析的能力；
61 Ability to be trained and work closely with other function;
具有被培训和能够与其他部门同事共同合作的能力；
61 Excellent communication skills (both verbal and written) and interpersonal skills are required, fluent in English and Chinese;
较好的沟通能力（口语和写作）以及人际交往能力，中英文流利；
61 Excellent structured organization skills to meet tight deadline.
优秀的组织能力，能够在截止时间前完成相应工作。
Preferred Experience 优先考虑
61 Adequate understanding of ICH Quality guidelines, including: stability program, quality of biotechnological products, pharmaceutical quality management, and quality risk management;
熟悉ICH质量指南，包括：稳定性程序，生物技术产品的质量，制药质量管理以及风险管理；
61 Expert knowledge of Good Manufacturing Practice of China, EU, and USA related to Quality Management Systems and Quality Control;
熟悉中国cGMP，欧盟cGMP以及美国的相关质量管理体系和质量控制法规；
61 Sound understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities;
熟悉中国药典、美国药典和欧盟药典的区别，以及其中生物制品和关键公用设施的内容；
61 Thorough understanding of Mab development, manufacturing, and analytical process.
熟悉单抗的开发、生产和分析。