Joshua Nguyen
Seattle
Summary
Analytical Developer with extensive experience at Fred Hutch Cancer Center, specializing in CAPA management and regulatory compliance. Demonstrated success in method validation and SOP development, contributing to continuous improvement initiatives. Proficient in HPLC and adept at cross-functional collaboration, maintaining high-quality laboratory standards.
Overview
6
6
years of professional experience
Work History
Analytical Developer / QC Associate II
Fred Hutch Cancer Center
Seattle
05.2023 - Current
- Led CAPA investigations and implemented corrective actions to resolve non-conformances, ensuring cGMP compliance.
- Managed deviation reports and change control processes for equipment onboarding and maintenance.
- Developed and revised SOPs for analytical and microbiological assays, aligning with regulatory standards.
- Oversaw validation activities for analytical methods and equipment qualification including HPLC, UPLC, ELISA, qPCR.
- Directed onboarding of new laboratory instruments, ensuring integration into GMP workflows.
- Conducted microbiological assays including sterility testing, environmental monitoring, and endotoxin testing.
- Prepared culture media and maintained laboratory equipment.
- Conducted microbial testing on raw materials and finished products.
Quality Control Associate
AGC Biologics
Bothell
05.2022 - 05.2023
- Supported CAPA and deviation investigations for quality control processes.
- Conducted QC testing, including pH, osmolality, HPLC/UPLC, TOC, bioburden, and endotoxin.
- Authored and revised SOPs and batch records to ensure compliance with FDA regulations.
- Performed data verification and stability testing using LIMS for in-process monitoring.
- Assisted in change control activities and equipment qualification efforts effectively.
- Collaborated with cross-functional teams to address quality issues promptly.
- Developed and maintained standard operating procedures for laboratory practices.
Quality Control Analytical Chemist
ALK
Oklahoma City
02.2021 - 05.2022
- - Conducted method validation and troubleshooting for analytical instrumentation.
- - Participated in CAPA and deviation reporting for QC assays.
- - Performed testing (pH, protein, chloride, phenol, iron, elemental analysis, glycerin) and documented results to ensure GMP compliance.
Lab Technician
ALK
Oklahoma City
03.2019 - 02.2021
- - Prepared solutions, performed pH and conductivity testing, and maintained laboratory cleanliness.
- - Supported QC team in routine microbiological testing and environmental monitoring.
Education
Bachelor of Science - Biochemistry
University of Oklahoma
Norman05.2021
Skills
- CAPA management and deviation investigations
- Change control and equipment onboarding
- Analytical techniques: HPLC, UPLC, ELISA, SDS-PAGE, IEF, Western blot, qPCR
- Microbiology assays: Gram stain, mycoplasma testing, TOC, conductivity, bioburden, endotoxin, environmental monitoring
- Validation and protocol development
- SOP development and training implementation
- Regulatory compliance: GMP, FDA, FACT standards
- Root cause analysis and continuous improvement
- Data analysis tools: LIMS, SmartSheet
- Method validation
- Change control
- SOP development
Timeline
Analytical Developer / QC Associate II
Fred Hutch Cancer Center
05.2023 - Current
Quality Control Associate
AGC Biologics
05.2022 - 05.2023
Quality Control Analytical Chemist
ALK
02.2021 - 05.2022
Lab Technician
ALK
03.2019 - 02.2021
Bachelor of Science - Biochemistry
University of Oklahoma
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