Hwaien Huang

黃懷恩

QA/Compliance

  New Taipei City, Taiwan

  [email protected]

  886+937-897-543

Hi, my name is Hwaien. I am working for a biotechnology company which is dedicated to the cord blood stem cells related development. I work as quality assurance(QA). In this job experience, I have to oversee and collect any deficiency which happens in the routine work at company. If the deficiency  belonged to SOP problem,  I would revise the SOP's content which is according with the decision of QA department. Because of new laws of biopharmaceutical, I collect these new laws and create file which can be used to compare with the old version one's. At product control, I audit and manage the position of the products such as cord blood and umbilical cord tissue. Though I don't have work experience in food industry, I believe that the experience in biotechnology company is suitable in it.

Thanks for spending time reading this curriculum vitae. I hope that you can find the expectant person for this job position.

工作經歷

QA/Compliance  •  Stemcyte Taiwan CO., LTD. 台灣永生細胞股份有限公司

三月 2019 - Present

  • Assist in organizing the case of the internal quality assessment(IQA) system that includes reporting of errors and accidents, customer complaints, adverse reactions and deviations from standard operation procedure (SOP).
  • If necessary, assist the SOP correcting with system failure or unusual event.
  • Assist the company with maintaining internal audit and facing external audit, such as TFDA or AABB.
  • Assist the contract auditing and updating. 
  • Oversee and audit the report of the product data which will be used in clinical or non-clincial operation.
  • Understand, explain and update the biotechnology regulation and biotechnology law.

學歷

2010 - 2014

National Chiayi University , 國立嘉義大學

Department of Food Science, Bachelor of Science

2015 - 2017

National Chung Hsing University, 國立中興大學

Department of Food Science and Biotechnology, Master of Science

Dissertation: Anti-enterovirus 71 activity and relevant mechanism of glycyrol in Rhabdomyosarcoma cells .


Licenses


  • Food technician of higher examination, 高考食品技師 
  • Professional Health Food Engineer-Entry, 保健食品初級工程師能力鑑定


Skills


  • Word                            
  • Excel
  • Powerpoint
  • SPSS
  • HACCP


Languages


  • Chinese
  • English(TOEIC 840)