Senior Specialist, QC Cell
Share
Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
责任描述和工作范围
参与QC细胞组日常检验及管理工作包括工作安排及跟踪文件体系建立等及时高效地完成组内检验任务并确 保检验活动符合国内外法律法规及公司内部质量要求主要工作如下
- 细胞组检验
- 参与细胞组实验室区域正常的日常管理并确保正常运行协助QC实验室质量体系的持续改进提高
- 参与QC细胞组相关分析方法接收方法确认检验方法标准操作规程及记录起草
- 组织QC细胞组分析方法验证实施及验证报告撰写保证分析方法的有效性
- 主导QC细胞组复杂仪器设备标准操作规程及记录起草并参与文件的审核
- 按计划组织人员对物料慢病毒载体及CAR-T等样本的放行检验及质量研究检验保证检验数据的真实性和 可靠性并组织检验过程中参数的整理收集
- 参与制定QC细胞组相关中间品与成品的稳定性研究方案起草并组织人员按照方案完成稳定性研究实施
- 参与对QC细胞组配制试剂检测细胞库质控品等按照相关规定进行管理任职资格
任职要求
- 本科及以上学历药学生物学基础医学检验医学等相关专业3年以上生物制药行业QC经验至少2年以上GMP环境下工作经验具备细胞治疗相关经验者优先
- 英语六级及以上听说读写能力佳可英文写作如起草英文SOP方案调查报告等
- 具备细胞培养相关的理论知识熟练掌握贴壁细胞和悬浮细胞培养的基本操作具备T细胞HeLa细胞系培养经验优先
- 具备流式分析相关的理论知识熟练掌握流式分析相关的基本操作及BD流式细胞仪的使用具备BD Canto或Lyric流式细胞仪使用经验优先
- 具备CAR-T细胞培养效能及流式相关检验经验优先
- 具备分析方法验证操作及验证报告撰写经验优先
- 具备对检验结果进行趋势分析独立处理OOS偏差等质量事件经验优先
- 需适应细胞治疗行业快节奏及低容错率本岗位涉及的检验工作容错率较低需要具备较强的抗压能力并需要适应轮班或加班胜任高强度快节奏的检验任务
Date Posted
09-Jan-2026Closing Date
29-Apr-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Senior IC
Key Skills
- Academics
- Ale
- Asset Management
- Legal Operations
- Art And Craft
- Database Administration
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
