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崗位職責(zé):
1. 負(fù)責(zé)日常的生物制品原液/成品的放行檢測(cè)、中間樣品檢測(cè)、穩(wěn)定性研究及檢驗(yàn)儀器的日常維護(hù)、保養(yǎng)、驗(yàn)證。
Responsible for release testing of DS/DP, in-process testing, stability studies, and daily maintenance and verification of analytical instrument.
2 .參與制訂CE、iCIEF、蛋白含量（UV280）等分析方法的驗(yàn)證方案、開(kāi)展驗(yàn)證實(shí)驗(yàn)、撰寫驗(yàn)證報(bào)告、SOPs、申報(bào)資料的準(zhǔn)備及相關(guān)資料歸檔工作。
Write and revise transferring and validation protocol, reports and SOPs for CE, iCIEF, protein content (UV280) and other analysis methods. Perform validation experiments, prepare application documents and archive related materials.
3. 識(shí)別理化檢測(cè)相關(guān)的異常、OOS/OOT/OOE、偏差等質(zhì)量問(wèn)題，并調(diào)查分析、改進(jìn)。
Identify quality issues such as abnormalities, OOS/OOT/OOE, and deviations related to physical and chemical testing, and investigate, analyze, and improve them.

任職要求:
1. 至少本科2-4年、碩士1-2年生物大分子藥品生產(chǎn)企業(yè)QC經(jīng)驗(yàn)。
With min. 2-4 years of bachelor's degree and 1-2 years of master's degree in QC experience in biologics manufacturers.
2. 分析化學(xué)、藥物分析、生物化學(xué)、藥學(xué)等相關(guān)專業(yè)。
Analytical chemistry, Drug analysis, Biochemistry, Pharmacy and other related majors.
3. 對(duì)CE（Maurice&PA800 Plus）等儀器有所了解，有使用還原及非還原CE、蛋白含量（UV280）等方法分析蛋白類藥物的經(jīng)驗(yàn)者優(yōu)先。
With hands-on experiences with reduced and non-reduced CE-SDS and protein content (UV280) and other analytical methods is preferred.
4. 了解GMP規(guī)范和要求，對(duì)ChP、EP、USP、ICH、PDA等相關(guān)法律、法規(guī)、技術(shù)指導(dǎo)原則有一定了解。
Understand GMP requirements, and have a certain understanding of relevant regulations, and technical guidelines such as ChP, EP, USP, ICH, and PDA.
5. 英文讀寫能力良好，可以閱讀英文文獻(xiàn)，翻譯、撰寫英文文件。
Good English reading and writing skills, able to read, write and translate documents.
6. 誠(chéng)實(shí)正直、好學(xué)敬業(yè)、注重細(xì)節(jié)、樂(lè)于溝通，具有良好的團(tuán)隊(duì)協(xié)作能力。
Honest and upright, eager to learn and dedicated, pay attention to details, willing to communicate, and have good teamwork skills.