Summary
Overview
Work History
Education
Skills
Timeline
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Richy Nguyen

Orange,California

Summary

Results-driven professional with expertise in managing the full project lifecycle, ensuring seamless operations, planning, and process execution to meet client needs. Experienced scientific leader committed to maintaining high-quality, efficient, and timely laboratory functions, contributing to organizational success and growth. Collaborative manager skilled in leading teams and cross-functional staff to implement process improvements, enforce quality control standards, and troubleshoot challenges, while upholding best practices, safety, and budgetary constraints.

Overview

5
5
years of professional experience

Work History

QC Specialist -Stability / Project Manager

Siegfried
Irvine, CA
04.2023 - Current
  • Led cross-functional teams in the planning and execution of pharmaceutical stability programs, ensuring compliance with regulatory guidelines (ICH, FDA, EMA)
  • Developed and maintained detailed project plans, timelines, and budgets to support product stability studies across the product lifecycle, including development, registration, and commercial phases.
  • Oversaw the full stability program lifecycle—from initiation and protocol design to execution, monitoring, and final reporting—ensuring timely delivery of data for regulatory submissions and shelf-life determination.
  • Coordinated routine cross-functional meetings with internal stakeholders and external partners; documented and tracked action items to drive accountability and study progression.
  • Worked closely with departments such as Analytical Development, Quality Assurance, Regulatory Affairs, and Manufacturing to align stability activities with broader project goals.
  • Contributed to the development of protocols, change controls, and deviations related to stability studies, ensuring data integrity and GMP compliance.
  • Managed outsourced stability testing at contract labs and third-party manufacturing organizations, ensuring timely sample pulls, testing, and data delivery.
  • Recognized for strong organizational, communication, and relationship-building skills, enabling seamless coordination of complex stability projects across global teams.
  • Led internal and external audits and regulatory inspections (e.g., FDA, EMA) as the laboratory subject matter expert (SME), providing documentation, addressing inquiries, and ensuring inspection readiness.

Lab Coordinator

Siegfried
Irvine, CA
05.2021 - 04.2023
  • Coordinate day-to-day laboratory operations to ensure timely execution of analytical testing and compliance with GMP/GLP standards.
  • Manage scheduling and prioritization of sample testing, equipment usage, and personnel assignments to support project timelines and manufacturing needs.
  • Maintain laboratory inventory, including ordering and receiving of reagents, consumables, and reference standards, ensuring uninterrupted workflow.
  • Ensure proper documentation of laboratory activities in notebooks, logbooks, and electronic systems (e.g., LIMS), maintaining data integrity and audit readiness.
  • Collaborate with cross-functional teams including Quality Control, Quality Assurance, and R&D to align lab activities with project goals and regulatory expectations.
  • Participate in investigations, CAPAs, and change controls related to lab operations, equipment, or deviations.
  • Prepare for and support internal and external audits and inspections by regulatory agencies (e.g., FDA, EMA).

Senior Lab Technician

Orange Coast Analytical
Tustin, CA
10.2020 - 05.2021
  • Conducted environmental testing and analysis of soil, water, air, and waste samples to identify contaminants and ensure regulatory compliance with environmental laws and standards.
  • Analyzed and interpreted chemical data, providing actionable insights for environmental risk assessments and regulatory reporting.
  • Managed and maintained laboratory equipment, ensuring proper calibration, troubleshooting, and compliance with quality control and safety standards.

Education

Bachelor of Science - Chemistry

University of California, Irvine
Irvine, CA
06-2019

Skills

  • Project management
  • Regulatory compliance
  • Stability testing
  • Data analysis
  • Quality assurance
  • Protocol development

Timeline

QC Specialist -Stability / Project Manager

Siegfried
04.2023 - Current

Lab Coordinator

Siegfried
05.2021 - 04.2023

Senior Lab Technician

Orange Coast Analytical
10.2020 - 05.2021

Bachelor of Science - Chemistry

University of California, Irvine

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Richy Nguyen