崗位職責 Responsibility 1. 負責原輔料、包裝材料及成品取樣、檢驗。 Responsible forsampling, inspection of raw materials, packaging materials and final products. 2. 獨立錄入電子數據并出具相關檢驗報告,確保檢驗報告的真實有效。Input electronic data independently and issue relevant inspection reports. Ensure the inspection reports are true and valid. 3. 協助上司進行質量偏差調查Assist the supervisor in quality deviation investigation 4. 執行實驗室日常檢驗工作(理化),支持工藝用水及廠房環境的月度檢測和監測工作 Perform dailylaboratory inspection (physicochemical), support the monthly inspection and monitoring of process water and plant environment 5. 協助對實驗室相關的檢驗儀器進行管理,校正和維護,確保檢驗儀器可支持實驗室檢驗工作以及相關檢驗數據的有效性。Assist in the management, calibration and maintenance of laboratory related inspection instruments. Ensure that the test equipment can support the laboratoryinspection task and the validity of the relevant test data. 6. 協助產品外部檢驗的送檢,報告整理歸檔Assist product external inspection submission, report filing Medical Technology 7. 協助實驗室檢驗試劑,耗材的管理,包括采購,入庫和定期盤點,保證足夠的實驗用試劑及耗材可支持到實驗室檢驗工作。Assist lab in the management of test reagents and consumables, including purchasing, warehousing and regular inventory, to ensure adequate test reagents andconsumables for laboratory testing. 8. 協助工程師進行檢驗儀器和測試方法的驗證Assist engineer to validate test instrument and test method 9. 協助相關OOS/OOT的調查過程,并完成調查報告Assist in OOS/OOT investigation process and complete investigation report 10. 完成上司交代的其它工作任務Complete other tasks assigned by superior 任職資格 Qualification ◆大專及以上,化學類、化工類、制藥、生物工程、機械相關專業 Senior college or above,Chemistry, chemical engineering, pharmaceutical,biological engineering, machinery or related major ◆ 熟練掌握醫療器械化學檢驗操作,熟練使用和維護常規理化檢驗設備(如GC/HPLC/酶標儀等)Good at the chemical inspection of medical equipment, familiar with the use and maintenance of routine physical and chemical inspection equipment (suchas GC/HPLC/ elisa machine, etc.) ◆ 熟練掌握醫療器械化學檢驗標準,如GB/T14233,藥典Good command of chemical inspection standards for medical devices, such as GB/T14233, pharmacopoeia ◆ 熟悉醫療器械化學檢驗方法,如TOC、工藝用水全性能Familiar with chemical test methods of medical devices, such as TOC, process water integrity ◆ 熟悉使用WORD、EXCEL等辦公軟件Familiar with OFFICE software such as WORD, EXCEL. ◆ 良好個人衛生習慣Good personal hygiene ◆ 能嚴格遵守公司潔凈車間及實驗室行為管理規范Can strictly abide by the company clean workshop and laboratory behavior management code ◆ 具有良好的溝通協調能力Good communication and coordination skills ◆ 細致嚴謹、較強的責任心 Meticulous and rigorous, strong sense of responsibility ◆ 快速學習能力、團隊合作精神Quick learning ability and team work spirit