工作职责:
1.组织实施物理和化学相关检测项目（如色谱类、光谱类、电化学类以及普通物化反应类）的检验。根据检测计划，按期完成检验工作。
Organize and implement experimental activities on testing related to physical and chemical items, e.g., chromatography, spectroscopy, electrochemistry, and general physicochemical reactions. Complete the testing work on schedule according to plan.

2.负责起草操作类的SOPs，包括分析方法、仪器操作。
Responsible for drafting SOPs related to method and instrument operation.

3.负责理化相关分析方法验证方案报告的起草和审核工作，如HPLC\GC\UV\水分\电泳等仪器分析方法。
Responsible for drafting and reviewing validation protocol\reports of analytical method related to physicochemical method. For example: Instrumental analytical methods such as HPLC\GC\UV\Moisture\Electrophoresis etc.

4.检验成本的核算。
Responsible for carrying out the account of testing costs.

5.负责管理、维护保养检验设备，确保检验设备可正常运行且在有效期内。协助主管完成对新设备的安装、调试、校准、确认以及设备档案的建立工作。
Responsible for the management and maintenance of instruments to ensure that the instruments can be running properly and within the validity period. Assist supervisors in the installation, commissioning, calibration, and validation of new instruments as well as the creation of equipment files.

6.负责在管辖区内推行5S的管理，并负责管理区域内的检验设备，组织人员开展设备维护保养工作。确保实验室现场设备可正常运行，在有效期内。
Responsible for the implementation of 5S management and equipment management in the jurisdiction of the area, organizing personnel to carry out maintenance of equipment. To ensure that equipment in QC can be operated normally, within the validity period.

7.完成QC经理分配的其他工作和职责。
Any other job and responsibilities assigned by QC manager.
任职资格:
1.生物药品相关经验，抗体药优先，有2年以上团队管理经验

2.负责保证小组内所有成员的活动符合GMP的要求。
Be responsible for assuring that all the activities for group members are in line with GMP requirement.

3.严格按SOP进行操作，并真实地、及时地、准确地完成记录填写和数据处理，及时归档检验记录。
Operations in strict accordance with SOPs, and to complete record filling and data processing truthfully, timely and accurately, and to file analytical records in a timely.

4.组织人员完成验证相关工作；
Organize and implement method validations;

5.协助QC经理，对相关人员进行上岗前培训和继续培训。
Assist the QC manager to conduct pre-service training and continuous training for relevant personnel.

6.组织实验室的OOS、偏差调查，以及相关的变更控制；
Responsible for conducting investigations of OOS , deviations and related change control;