Senior Specialist, QC Cell job opportunity at AstraZeneca.

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AstraZeneca Senior Specialist, QC Cell
Experience: General
Pattern: full-time
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QC Cell

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degreeGeneral
loacation Suzhou – Biopharmaceutical Industrial Park, China
loacation Suzhou – Bioph..........China

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-2026 Closing Date 29-Apr-2026 AstraZeneca 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.

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