Job description
此QC职位负责QC各种理化、仪器和生物学方法检测，支持生物药的生产和产品放行。

Responsibilities
1. 负责重组蛋白、抗体等生物药理化分析方法检测工作，如SEC、CEX、CE-SDS、iCIEF、肽图、N-糖型、吐温等包括但不限于；
Responsible for the detection of biochemical analysis methods for recombinant proteins and antibodies, such as SEC, CEX, CE-SDS, iCIEF, peptide map, N-glycan profile, PS80/20, etc.
2. 负责生物产品（单抗、双抗、融合蛋白等）相关理化分析方法的开发，包括但不限于液相色谱、质谱、电泳等，以解决创新项目方法开发的难题；
Responsible for the development of physicochemical analysis methods related to biological products (monoclonal antibody, double antibody, fusion protein,etc.), including but not limited to liquid chromatography, mass spectrometry,electrophoresis, etc., to solve the problem of innovative project method development;
3. 支持QC方法相关的troubleshooting及一些抗体相关的特殊研究；
Support troubleshooting related to QC method and some special research related to antibodies.
4. 负责撰写检测方法SOP、各类研究方案和报告以及方法验证和转移相关文件。支持分析方法开发、优化、方法确认、方法转移或验证工作；
Responsible for writing test method SOP, various research programs and reports, as well as method validation and transfer related documents; Support analysis method development, optimization, method validation, method transfer or verification;
5. 支持异常事件的调查和研究工作；
Support the investigation and research of abnormal events;
6. 承担项目管理工作，根据公司项目进度按时推进本部门的工作，包括但不限于文件体系的管理以及设备验证及日常维护工作；
Responsible for project management, according to the company's project schedule to promote the department's work on time, including but not limited to file system management, equipment verification and daily maintenance。
7. 符合环保、健康和安全的方针政策；
Comply with environmental, health and safety policies；
8. 完成上级安排的其他工作。
Complete other tasks assigned by superiors.

Qualifications
1、药学、化学、生物学或相关学科硕士或以上学历；
College degree or above in Pharmacy, chemistry, biology or related discipline；
2. 能独立完成方法转移、确认、验证（药典法规以及文献阅读，实验设计，报告汇总）；
Be able to independently complete method transfer, validation and verification (pharmacopoeia regulations and literature reading, experimental design, report summary);
3. 熟悉GMP体系中QC的工作要求；
Familiar with QC requirements in GMP system.
4. 精通偏差、OOS/OOT、等实验室异常调查流程；
Proficient in deviation, OOS/OOT, and other laboratory anomaly investigation processes.
5. 具有较强的团队合作意识，具有较好的沟通交流能力，具有一定的抗压能力。
Have a strong sense of teamwork, good communication skills, have a certain ability to work under pressure.