Job Responsibilities 工作職責： 1. Generate all necessary test procedure, perform analysis of in-process sample, drug substance, drug product and stability study sample under cGMP standards. 撰寫所有必須的檢測規程，根據檢測規程，依照相關cGMP標準對中間樣品，原液，制劑和穩定性樣品進行分析檢測； 2.Perform routine testing such as endotoxin, bioburden and sterility, understand technical aspects of the job, best practices, and adhere to cGMP compliance. 執行內毒素，微生物限度和無菌的日常檢測，理解工作的技術原理，最佳做法，并遵守cGMP合規性； 3. Generate method verification protocol under ICH/USP/EP/CP guidelines, and draft method verification report after the completion of experiment. 根據ICH/USP/EP/CP指南生成方法確認方案，實驗執行完成后起草方法確認報告； 4.Execute method transfer/qualification/validation of endotoxin, bioburden and sterility. 執行內毒素，微生物限度和無菌的方法確認； 5. Perform moderate data analysis and trending, document work according to GMP and notify management. 進行適當的數據分析和趨勢分析，根據GMP進行文件工作并通知管理人員； 6.Handle the quality event such as change control, deviation and CAPA related to the testing. 負責處理與檢測相關的質量事件，例如變更，偏差和糾正和預防措施。 Qualification 任職資格; 1.B.S./M.S. degree. 本科/碩士學歷。 2.Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience. 本科及三年以上工作經驗，或研究生及一年以上工作經驗。 3.Extensive experience in micro related knowledge and testing skills. 具有豐富的微生物相關背景知識和檢測技能。 4.Excellent verbal and written communication skills in English. 有良好的英語口語和寫作能力。