Job Description :

1. Responsible for the inspection of raw materials, including record filling, data analysis, report issuance and other related work.负责试剂原材料的检验工作，包括记录填写、数据分析、报告出具及其他相关工作。

2. Responsible for the inspection of reagent semi-finished products and finished products, including record filling, data analysis, report issuance and other related work.负责试剂半成品和成品的检验工作，包括记录填写、数据分析、报告出具及其他相关工作。

3.Support the resolution of deviations or non-conformances related to inspection processes.支持与检验流程相关的偏差或不合格项的处理。

4. Apply strong technical knowledge to address quality-related issues and troubleshoot issues as they arise. 运用技术知识处理质量相关问题，并能在问题出现时进行排查。

5.Maintain a clean and organized work environment in accordance with 5S and Lean Quality principles.按照5S和精益质量原则，实验室环境维护。

6. Draft, maintain, and review Work Instructions and Standard Operating Procedures in compliance with ISO13485/9001 requirements.起草、维护和审核作业指导书及标准操作规程，确保符合ISO 13485/9001的要求。

7.Perform other duties as assigned by the supervisor.完成主管分配的其他任务。

Job Qualification :

1.Bachelor’s or Master’s degree with over 2 years of relevant experience and capabilities in the biopharmaceutical or medical device industry. Experience in in vitro diagnostic reagent testing or development; Candidates with experience in antibody reagent products are preferred.拥有学士或硕士学位，具备2年以上生物制药或医疗器械行业相关经验；有体外诊断试剂检测或开发经验者优先；有抗体类试剂产品经验者优先。

2.Experience with flow cytometry and cell culture operations is a plus.有流式细胞术和细胞培养操作经验者优先。

3.Strong organizational and prioritization skills.具备良好的组织能力和事务优先能力。

4.Good oral and written communication skills, as well as strong teamwork, organizational, and computer skills.具备良好的口头和书面沟通能力，良好的团队合作、组织及计算机操作能力。

5.Highly responsible and conscientious work attitude.工作态度高度负责，认真细致。

6.Good English reading and writing skills; fluent spoken English is a plus.具备良好的英文阅读和写作能力；口语流利者优先。

7.Strong quality awareness: knowledge of ISO 13485/9001 quality systems is required, and familiarity is preferred.具有较强的质量意识：掌握ISO 13485/9001质量体系的相关知识，有相关经验者优先。

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