Typical Accountabilities 主要职责 Specific Responsibilities/Tasks 具体职责/任务 Routine work 日常工作 Mangement of instrument Report any deviation timely, lead critical deviation/OOS investigation /OOS的调查 Issue and revise specification, test method and batch analysis record of starting materials and finished products, and
The Opportunity: Executes day-to-day lab operations & support objectives at customer facilities, following a varied set of procedures, focused on minimizing laboratory workflow interruptions. Problems and issues are typically less concrete and frequently changing, and are
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 Posted05-Jun-2026 Closing Date30-Oct-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
Major responsibilities On shop floor quality oversight for cell therapy products to ensure product batch is manufactured according to approved procedure and in compliance with current GMP requirements Performs the QA review and approval of the
Brief Job Description 工作描述简述 Finish routine analytical work for products accurately. Maintain the instruments in good status, and develop professional skills. Finish routine management of reference standards / reagents / consumables to support lab tests performed
The Opportunity: Workers engaged for short-term needs or specific projects Technician Scientific Support, Onsite Job Objectives: Follow up on production projects, deliver on time, ensure the smooth progress of production projects, and complete method development, transfer,
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Shanghai, China | full time | Job ID: 11516 Your contribution: Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered Represent external/global QC in multidisciplinary project
PLAY, GROW and WIN To be a part of Virtuos means to be a creator. At Virtuos, we harness the latest technologies to make games better and more immersive than ever before. That is why we
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and
与我们携手施展你的超能力! 探索未知、打破壁垒、勇于发现,你准备好了吗?你有宏图大志正待实现,我们同样雄心勃勃。我们遍布全球的员工热爱科技创新,以医药健康、生命科学和电子科技领域的解决方案,切实改善人类生活。我们怀揣远大梦想,热忱关爱员工、客户、患者和人类居住的这颗星球。因此我们一直在寻找永葆好奇心的你,与我们一路同行、敢想敢做,把不可能变为可能! 在电子科技,我们所做的一切都是为了成为众多企业推进数字化生活的幕后推手。我们致力于作为值得信赖的供应商,为电子、汽车和化妆品行业提供高科技材料、服务和特种化学品。我们培养了一个全球协作的组织,我们的员工热情好胜、秉持客户至上、充满好奇心且行动敏捷。我们齐心协力突破科学的极限,为客户创造更多可能。 Senior Tolling Quality Engineer We are seeking an experienced Senior Tolling Quality Engineer to oversee quality assurance and continuous improvement activities at our tolling (contract manufacturing) partner sites in China. In this role,
ACCOUNTABILITY: Supports all processes regarding customer complaints , statistical quality control (SQC), out of specification (OOS), and deviation management from QC perspective, including but not limited to all Standard Work Process (SWP), Management System, and analytical responsibilities.
Job Description SummaryProduct quality review associated with the manufacturing process. Accountable for the quality of own work. Subject to direct operations supervision/prescribed work instructions/systems checking. Executes within a well-defined operations framework. There is generally a step
Job title职位名称:Supervisor of Sterile Process Compliance无菌工艺合规主管 Location工作地点: Beijing北京 About the job工作职责 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply
In Accenture, potrai portare la tua visione innovativa al cuore del cambiamento per trasformare interi settori di mercato. Modella il futuro del business e della tecnologia sviluppando soluzioni all’avanguardia in grado di generare nuovo valore. Il
LE TUE RESPONSABILITA’ Inserito all’interno della funzione Category & Business Intelligence, e rispondendo alla Senior Category Chilled and Frozen, ti occuperai di: monitorare le performance relative alle categorie merceologiche di propria competenza attraverso l’elaborazione di specifiche