SOONWON PARK
Cheongju-si
Summary
Quality Control Specialist with 6 years of experience in the pharmaceutical industry, specializing in laboratory management, AMV, immunology testing, and instrument qualification. Skilled in immune antigen-antibody assays (ELISA, SRID) for vaccine products and currently leading analytical method transfer (AMT) for mRNA products, including GAP analysis and instrument qualification.
Experienced in instrument maintenance and requalification (IOQ) for ELISA (VERSA Max) and qPCR (FAST 7500), ensuring compliance with GMP standards. Proficient in OOT investigations, root cause analysis, and SOP development and revision to support regulatory compliance and laboratory best practices.
Overview
7
7
years of professional experience
Work History
QC Manager
GC Biopharma Corp.
05.2018 - Current
- Analytical Method Transfer (AMT) for New Products : Conducted GAP analysis for technology transfer of mRNA-based analytical methods, assessing instrument suitability and test feasibility.
Introduced and qualified new laboratory instruments, including (Zetasizer, Fragment Analyzer, ChemiDoc, Fluorescence Microplate Reader) to support analytical method implementation. - Analytical Method Validation (AMV) and Immunological Testing : Developed validation protocols and reports for identification and content assays, focusing on ELISA and SRID methods.
Performed immunological testing for Varicella, Influenza, and Tdap vaccines, ensuring assay robustness and reproducibility. - Instrument Management & Qualification : Conducted routine maintenance, requalification (IOQ), and software upgrades for laboratory instruments, including ELISA (VERSA Max) and qPCR (FAST 7500) to enhance compliance with audit trails.
Ensured proper operation, calibration, and qualification of essential laboratory equipment to maintain test accuracy and reliability. - OOT Investigation & Documentation : Conducted OOT (Out of Trend) investigations and prepared comprehensive reports to identify root causes.
Established and revised Standard Operating Procedures (SOPs), ensuring alignment with GMP standards and laboratory best practices.
Education
Bachelor of Science - Genetic Engineering
Kyung Hee University
Yongin-si, South Korea09-2018
Skills
- Risk assessment capabilities
- Corrective and preventive actions
- Quality assurance expertise
- Performance metrics monitoring
- Documentation review
- Teamwork and collaboration
- Problem-solving abilities
- Multitasking Abilities
- Quality control management
- Documentation control
- Equipment calibration
Languages
Korean
Native language
English
Upper intermediate
B2
Timeline
QC Manager
GC Biopharma Corp.
05.2018 - Current
Bachelor of Science - Genetic Engineering
Kyung Hee University
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