QC活性高级研究员

岗位要求：

1.具有细胞生物学、生物化学、分子生物学或相关学科的博士学位，或具有学士或硕士学位并且有至少5年制药/生物技术行业或学术环境的经验。

Ph.D. degree in cell biology, biochemistry, molecular biology or a

related discipline, or BS or MS degree with a minimum of 2 years’ experience in

pharmaceutical/ biotech industry or in an academic setting.

2. 在分析技术方面有一定的经验，包括生物活性检测（ELISA,Cell based Assay）。

Must be experienced in analytical techniques, including bioassay

assays(ELISA, Cell based Assay ).

3. 熟悉移液器、培养箱、酶标仪等设备。

Be familiar with pipettes,

incubator ,plate ready and other equipment.

4. 较强的中英文书面和口头沟通能力以及出色的人际交往能力是工作的基本要求。

Strong

written and verbal communication skills in both Chinese and English, along with

excellent interpersonal skills, are essential requirements for this position.

5. 具有问题发现和解决能力。

Demonstrated ability to identify and solve problems..

6. 可以熟练的阅读、撰写并且理解英文文档。

Be skilled at reading, writing and understanding of English

documentation.

7.具有 GMP 相关工作经验者优先。

GMP experience is preferred.

工作内容：

1.撰写生物测定方法操作规程，并按照相关的AMP、生物测定方法和方案完成方法验证/确认。

Write AMPs of the bioassay methods, and follow related AMPs, Bioassay methods and protocols to complete method validation/qualification

2. 处理生物活性的数据，使符合标准曲线、对照和其他系统适用性参数的要求。

Process data of bioassay to meet the requirements of standard curve, control values, and other system suitability parameters.

3. 审核相关文件，包括实验记录、原始数据和分析报告。

Review related-documents, including worksheets, original data and analytical reports.

4. 撰写/审核相关文件，包括确认/验证/测试的方案/计划等。

Write / review related-documents, including qualification / validation / test protocols / plans etc.

5. 处理DS/DP放行、稳定性研究和确认/验证过程中的质量事件，以及OOS或者OOT引起的实验室调查和偏差。

Conduct quality events within DS/DP releasing testing, DS/DP stability studies and qualification/validation, and Lead laboratory investigation for OOS or OOT and deviations.

6. 为内部/外部审计提供协助。

Provide assistance to internal / external audit.