岗位职责:

工作职责：

工作内容包括，但不限于：

1.根据研究数据准备生物分析方法验证和样品分析报告，确保报告准确反映生物分析研究结果。

2.与主要研究者/专题负责人、质量保证部和研究监察员（来自申办方）交流，确保研究报告遵循时间的要求。根据各方意见更新报告。

3.根据申办方的要求提供项目文件的翻译。

4.为BAS员工提供必要的质量控制/报告撰写相关培训。

5.对项目数据和报告进行质量控制检查。

6.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。

7.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。

8.对QC相关工作的SOP进行更改。

9.进行SOP中规定的相关工作，以及根据国际经贸合作组织美国食品药品监督管理局和中国国家药品监督管理局（原CFDA）等GLP法规和其他适用的法规开展工作。

10.作为偏离协调员管理偏离。

1.Prepare bioanalytical method validation and sample analysis report based on study data and ensure that the report accurately reflect the bioanalytical study results.

2. Interact with Principal Investigator/Study Director, QA and study monitor from sponsor to ensure the timeline of study report preparation is followed. Update the report according to the comments from different parties.

3. Provide translation to study documents per sponsor’s requirements.

4. Provide necessary training to BAS employees for QC/report writing related topics if needed.

5. Conduct QC review of study data and report.

6. Conduct routine facility walk-through check to help to maintain consistent high level compliance of lab maintenance.

7. Coordinate with Project Manager, Principal Investigator/Study Director and QA for review and corrective actions to meet project timelines.

8. Initiate any changes on SOPs of QC related works.

9. 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.

10. Serve as deviation coordinator to manage deviation.

任职要求:

任职资格：

1.拥有理工科或者文科学士、硕士或博士学历，具备分析化学方面的工作经验或培训，或同等资历。

2.熟悉生物分析相关工作流程。

3.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。

4.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。

5.具备熟练阅读、理解，书写英语文档能力。

1. BS, MS or Ph.D. degree in a science or liberal art discipline with experience or training in analytical chemistry, or equivalent experience.

2. Must be familiar with process of bioanalytical studies.

3. Strong communication skills, including reading, writing and verbal communications, and outstanding interpersonal skill are essential job requirements.

4. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

5. Proficient in reading, comprehension and writing in English.