BAS-免疫化学质控专员(J25213)

Develop and maintain AI-assisted quality control and study report generation tools (such as automated data review scripts, templated report generation, and intelligent identification of anomalies/deviations), continuously enhancing the efficiency of quality control and report writing. 开发并维护AI辅助质控和项目报告撰写工具（如数据自动审核脚本、模板化报告生成、异常/偏离智能识别），持续提升质控和报告撰写效率。

Provide necessary training to BAS employees for QC related topics if needed. 为BAS员工提供必要的质量控制相关培训。

Conduct QC review of study data and report. 对项目数据和报告进行质量控制检查。

Conduct routine facility walk-through to help to maintain consistent high-level compliance of lab maintenance. 对实验室进行例行检查以保持实验室持续处于良好的秩序下。

Coordinate with Project Manager, Principal Investigator/Study Director and QA for review and corrective actions to meet project timelines. 配合项目经理、主要研究者/专题负责人和质量 保证 部 (QA)进行检查和纠正措施，以满足项目进度要求。

Initiate any changes on SOPs of QC related works. 对QC相关工作的SOP进行更改。

Perform duties complied with the related SOPs and according to OECD, USFDA and NMPA (previous CFDA), etc., GLP guidelines as well as other applicable regulations. 进行SOP中规定的相关工作，根据经济合作与发展组织，美国食品药品监督管理局和国家药品监督管理局（原 CFDA 等等 GLP 法规和其他适用的法规开展工作。

Serve as deviation coordinator to manage deviation. 作为偏离协调员管理偏离。

Possess a strong awareness of AI-driven data processing and automation, with the ability to use or quickly master Excel, SQL, Python, or low-code and large language model tools (such as Copilot, ChatGPT, Qoderwork, etc.) to support data review, study report writing, and process optimization. Maintain a keen sense of quality and compliance regarding AI-generated outputs, understand their limitations, and exercise prudent validation within GLP while properly managing data integrity and confidentiality. 具备较强的数据处理与自动化的AI应用意识，能使用或快速上手Excel/SQL/Python或低代码及大模型工具（如Copilot、ChatGPT、Qoderwork等）辅助数据审核、项目报告撰写与流程优化；对AI生成结果保持质量与合规意识，理解其局限性，能在GLP下审慎验证并妥善管理数据完整性与保密性。

Must be trained in or have experience with the requirements of USFDA, NMPA (previous CFDA) and OECD GLP guidelines as well as other applicable regulations. 必须具备美国食品药品监督管理局，国家药品监督管理局和经济合作与发展组织GLP法规要求的培训经历或者工作经验。

BS or MS degree in a science or liberal art discipline with experience or training in analytical chemistry, or equivalent experience. 拥有理工科或者文科学士或硕士学历，具备分析化学方面的工作经验或培训，或同等资历。

Must be familiar with process of bioanalytical studies. 熟悉生物分析相关工作流程。

Strong communication skills, including reading, writing and verbal communications, and outstanding interpersonal skill are essential job requirements. 具备工作基本要求的良好的沟通交流能力，包括阅读、书写和口头表达能力以及出色的人际交往技巧。

Must be able to openly share information and work in a team-oriented manner to accomplish performance objectives. 必须具备以团队目标为导向的积极分享信息的工作方式和团队协作精神。

Proficient in reading, comprehension and writing in English. 具备熟练阅读、理解，书写英语文档能力。