Jayden Lee
Toronto,ON
Summary
I have 1 year of experience in QC and 3 years in QA at pharmaceutical companies. I am familiar with GMP and knowledgeable about the requirements to be complied with in GMP facilities.
As a QA specialist, my main task was to investigate product issues received from customers or quality issues that occurred internally, and to identify the root causes of the issues.
Through this experience, I have a good understanding of various approaches(insights) to solve problems, and I have ideas for actions to prevent reoccurrence of problems.
Additionally, I excel at escalation by summarizing the issues in a PowerPoint presentation to discuss and resolve quality problems with multiple divisions.
**Work permit: valid until Jul 2026**
Overview
5
5
years of professional experience
Work History
Quality Assurance Analyst
Abbott Diagnostics Korea
Yongis-si in Korea
03.2020 - 04.2023
- Received customer complaints and inquiries, investigated the claimed issue cooperating with various divisions and generated investigation reports.
- Reviewed deviations reported from manufacturing, quality control or other resources, and coordinated the investigation.
- Conducted risk analysis and proceeded QI(Quality Incident) investigation or CAPA(Corrective Action and Preventive Action) based on risk level.
- Conducted complaint/QI(Quality Incident) analysis monthly, and yearly basis.
- Arranged audits by WHO, headquarter, MFDS and other GMP institutions.
Quality Control Analyst
Hanmi Pharmaceutical
Pyeongtaek-si
04.2019 - 01.2020
- Conducted sampling of manufacturing water and performed tests such as endotoxin, TOC, nitrate and conductivity to comply quality of manufacturing water.
- Recorded test results in compliance with GMP and DI(Data Integrity).
- Maintained SOPs as the latest revision, and conducted calibration for test equipment.
Quality Control Technician
Hyundai Pharm
Cheonan-si
09.2018 - 01.2020
- Performed sampling of raw material and reagent, and conducted tests based on specification and test method.
- Performed tests such as appearance, stability, content of API, dissolution, and impurity for final QC and stability tests of finished products.
- Reviewed and recorded test results obtained by HPLC, UV-vis, IR spectroscopy, and other test equipment.
Education
GMP Regulation And Quality Control Instruction
Korea Human Resource Development Institution
Chungju-si In Korea11-2019
Bachelor of Science - QA/QC in The Pharmaceutical Industry
Sunmoon University
South Korea02.2019
Skills
- Issue Investigation & Resolution
- Team collaboration
- Trend analysis
- Risk assessment
- Correction Action&Preventive Action Planning
- Documentation and Reporting
- Advanced level with MS office
- Chemical test with equipment
Timeline
Quality Assurance Analyst
Abbott Diagnostics Korea
03.2020 - 04.2023
Quality Control Analyst
Hanmi Pharmaceutical
04.2019 - 01.2020
Quality Control Technician
Hyundai Pharm
09.2018 - 01.2020
GMP Regulation And Quality Control Instruction
Korea Human Resource Development Institution
Bachelor of Science - QA/QC in The Pharmaceutical Industry
Sunmoon University
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