Yoo Jung Lee
East Brunswick,NJ
Summary
Quality Assurance/Regulatory Affairs Specialist with extensive knowledge of medical device, biologics, and drug review and evaluation
Overview
9
9
years of professional experience
Work History
QA Assistant Manager
Nano-Ditech Corp.
Cranbury, NJ
04.2023 - Current
- Quality System Regulation
- Establish, implement, and maintain the Quality Management System.
- Quality Activity
- Conduct quality audits to assess compliance with cGMP, ISO 13485, FDA QSR 21 CFR 820, EU IVD regulation and other applicable regulation requirements.
- Review standard operating procedures and revise or initiate new procedures and systems as needed.
- Ensure that the QMS is communicated with all employees by providing training to ensure continual compliance with cGMP, ISO 13485, FDA QSR 21 CFR 820, EU IVD regulation and other applicable regulation requirements.
- Provide management of QA function, including oversight of manufacturing device, inspection, labeling and packaging operations and documentation by performing routine ongoing audits on the shop floor.
- Perform review of records, and comments to assure that records are complete and accurate.
- Ensuring the monitoring, maintenance, and improvement of the quality of products through complaint investigation, failure investigation, product quality and risk assessment and CAPA activity.
- Ensure evaluation of, and reporting on, vendor quality systems.
- Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
o Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices. - Oversee product recalls.
- Communication
- Report evaluation of performance of quality management system and any need for improvement to head of quality department
Educator
LULULEMON
Busan, South Korea
01.2021 - 12.2021
- Accomplished brand promotion as NSO (New Store Open) with 20+ supervisors and employees
- Communicated with 100+ instructors (Yoga, Cross-fit, Running) for promotion and local activities
- Facilitated two yoga programs for foreign customers to foster product sale by providing interpreter services and instructing sports.
Translator
PAVETHEPATH
Busan, South Korea
04.2020 - 01.2021
- Assisted the blockchain and cryptocurrency startup by translating 2 conferences and 100+ articles between Korean and English to publish on the homepage and coordinating conferences for consulting and accelerator.
Student Assistant
DONG-GUK UNIVERSITY
Seoul, South Korea
01.2015 - 12.2018
- Mentored 10+ freshmen on cooperative skill development in microbiologic lab meetings every week; instructed 4 freshmen on laboratory experiments
- Coordinated a conference for lab cultural exchanges for 100+ students and planned cultural events
- Wrote a research paper 'Comparison of Regulatory Affairs in Private Pharmaceutical Companies in Korea and USA'.
Education
Master of Science in Regulatory Affairs -
Northeastern University
04.2023
American Language Program -
Columbia University
04.2020
Bachelor of Science in Biomedical Technology -
Dong-guk University
02.2019
Skills
- Microsoft Office Suite (Word, Excel, PowerPoint, Access)
- Korean (Native)
- English (Fluent)
- Japanese (Beginner level)
Websites
Projects
NORTHEASTERN KOREAN STUDENTS ASSOCIATION, Boston, MA, Vice-President, 01/2022, Present, Organized social activities to improve community building and create networking opportunities for 20 Korean students, Communicated with another university for recreational and social activities engaging 100+ Korean students COMPARISON BETWEEN KOREA AND US PHARMA COMPANIES, Seoul, South Korea, 09/2018, 12/2018, Interviewed two Korean Society of Food, Drug and Cosmetics Regulatory Sciences employees to gather information on the Korean pharmaceutical industry for a research project, Compared research infrastructure and range of drugs between the US and Korean pharmaceutical industries
Timeline
QA Assistant Manager
Nano-Ditech Corp.
04.2023 - Current
Educator
LULULEMON
01.2021 - 12.2021
Translator
PAVETHEPATH
04.2020 - 01.2021
Student Assistant
DONG-GUK UNIVERSITY
01.2015 - 12.2018
Master of Science in Regulatory Affairs -
Northeastern University
American Language Program -
Columbia University
Bachelor of Science in Biomedical Technology -
Dong-guk University
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