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職責(zé)描述： 工作職責(zé)： 工作內(nèi)容包括，但不限于： 1.根據(jù)研究數(shù)據(jù)準(zhǔn)備生物分析方法驗(yàn)證和樣品分析報(bào)告，確保報(bào)告準(zhǔn)確反映生物分析研究結(jié)果。 2.與主要研究者/專題負(fù)責(zé)人、質(zhì)量保證部和研究監(jiān)察員（來自申辦方）交流，確保研究報(bào)告遵循時(shí)間的要求。根據(jù)各方意見更新報(bào)告。 3.根據(jù)申辦方的要求提供項(xiàng)目文件的翻譯。 4.為BAS員工提供必要的質(zhì)量控制/報(bào)告撰寫相關(guān)培訓(xùn)。 5.對(duì)項(xiàng)目數(shù)據(jù)和報(bào)告進(jìn)行質(zhì)量控制檢查。 6.對(duì)實(shí)驗(yàn)室進(jìn)行例行檢查以保持實(shí)驗(yàn)室持續(xù)處于良好的秩序下。 7.配合項(xiàng)目經(jīng)理、主要研究者/專題負(fù)責(zé)人和質(zhì)量保證部QA進(jìn)行檢查和糾正措施，以滿足項(xiàng)目進(jìn)度要求。 8.對(duì)QC相關(guān)工作的SOP進(jìn)行更改。 9.進(jìn)行SOP中規(guī)定的相關(guān)工作，以及根據(jù)國際經(jīng)貿(mào)合作組織美國食品藥品監(jiān)督管理局和中國國家藥品監(jiān)督管理局（原CFDA）等GLP法規(guī)和其他適用的法規(guī)開展工作。 10.作為偏離協(xié)調(diào)員管理偏離。 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. 任職要求： 任職資格： 1.擁有理工科或者文科學(xué)士、碩士或博士學(xué)歷，具備分析化學(xué)方面的工作經(jīng)驗(yàn)或培訓(xùn)，或同等資歷。 2.熟悉生物分析相關(guān)工作流程。 3.具備工作基本要求的良好的溝通交流能力，包括閱讀、書寫和口頭表達(dá)能力以及出色的人際交往技巧。 4.必須具備以團(tuán)隊(duì)目標(biāo)為導(dǎo)向的積極分享信息的工作方式和團(tuán)隊(duì)協(xié)作精神。 5.具備熟練閱讀、理解，書寫英語文檔能力。 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.