QC专员（理化分析）

Job Responsibilities/工作职责
1. Generate all necessary test procedure, perform analysis of in-process sample, drug substance, drug product and stability study sample under cGMP standards;
撰写所有必须的检测规程，根据检测规程，依照相关cGMP标准对中间样品，原液，制剂和稳定性样品进行分析检测；
2. Perform routine testing such as pH, osmolality, UV, visible particle, Sub-visible particle, extractable volume, color, clarity, LC related assay, CE related assay, understand technical aspects of the job, best practices, and adhere to cGMP compliance;
执行pH, 渗透压，蛋白浓度，可见异物，不溶性微粒，装量，颜色，浊度，液相相关的检测，毛细管电泳相关的检测的日常检测，理解工作的技术原理，并遵守cGMP合规性；
3. Generate method transfer/qualification/validation protocol under ICH/USP/EP/CP guidelines, and draft method transfer/qualification/validation report after the completion of experiment;
根据ICH/USP/EP/CP指南生成方法转移/确认/验证方案，实验执行完成后起草方法转移/确认/验证报告；
4. Execute method transfer/qualification/validation of as pH, osmolality, UV, extractable volume, color, clarity, LC related assay, CE related assay;
执行pH, 渗透压，蛋白浓度，装量，颜色，浊度，液相相关的检测，毛细管电泳相关的检测的方法转移和方法确认/验证；
5. Perform moderate data analysis and trending, document work according to GMP and notify management;
进行适当的数据分析和趋势分析，根据GMP进行文件工作并通知管理人员；
6. Handle the quality event such as change control, deviation and CAPA related to the testing.
负责处理与检测相关的质量事件，例如变更，偏差和纠正和预防措施。
Job Requirements/岗位要求
1. Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience;
本科及三年以上工作经验，或研究生及一年以上工作经验；
2. Extensive experiences in analytical testing for protein analysis, such as HPLC, CE, MS, iCE3，UV, extensive experience in method development, qualification, validation and method transfer of physical-chemical methods;
具有蛋白质分析测试方面工作经验，如高效液相色谱、毛细管电泳、质谱、ICE3、紫外扫描等；具有在理化分析方法的方法开发、确认、验证和方法转移方面有丰富经验；
3. Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development, the basic statistics required in data analysis;
了解FDA和ICH指南以及与分析方法开发相关的GLP / GMP原则和数据分析所需的基本统计学；
4. Highly motivated, flexible, and multi-task;
高度积极性，灵活性和多任务解决能力；
5. Excellent verbal and written communication skills in English.
有良好的英语口语和写作能力。