2015年加入冠昊生物-细胞与干细胞中心，日常负责再生软骨生产、免疫细胞储存生产过程监督，文件系统维护、主持质量分析例会、设备工艺验证工作、自检等。1) 对整个文件系统进行升级，重建SOP、验证/确认方案及报告、质量标准、风险评估等质量文件模板，从内容上和格式上对整个文件系统进行更新，并建立文件数据库。2) 对设备仪器台帐、仪器外校内校台帐、留样台帐进行重新编号、统计、整理。3) 对整个生产区、检验中心进行定置管理，完成培训、实施及制度建立。4) 主持中心质量分析例会，负责日常偏差、风险项的讨论、解决方案落实等。5) 2015年参与了细胞与干细胞中心ISO9001:2008质量管理体系认证。I joined in Guanhao Biotech Co., Ltd Cell and Stem Cell Research Center in 2015. Routine jobs: production monitoring of Human Tissue Engineered Articular Cartilage Implant (ACI) and Immune Cells Cryopreservation, maintenance of QMS documentation, Equipment Qualification & Process Validation, self-inspection, etc.1) Upgrade the QMS documentation: rebuild the document template of SOP, Qualification Protocol & Report, Specification, Risk Assessment, and establish document database.2) Renumber & re-arrange of log books for equipment & instrument, instrument Calibration and Retention Samples. 3) Carry out Fixed Location Management for Production Area and Analytical Laboratory to establish and implement the management system. 4) Discussing deviation and risk in Risk Management Meeting to co-develop contingency plans as needed, and maintaining records of risk management.5) Take part in certification of ISO 9001:2008 Quality Management Systems in 2015.