Summary
Overview
Work History
Education
Skills
Timeline
Generic

Martin Vargas

Chula Vista,CA

Summary

Validation professional with solid background in ensuring compliance and product quality. Known for driving validation protocols and contributing to successful project outcomes. Highly reliable, adaptable, and skilled in working collaboratively to achieve team goals.

Overview

9
9
years of professional experience

Work History

Computer Validation Specialst

Statera Consulting
04.2024 - Current
  • Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
  • Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
  • Developed comprehensive validation plans, outlining objectives, timelines, and resource requirements for successful project execution.
  • Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Improved validation processes by implementing risk-based approaches and streamlining documentation.
  • Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
  • Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
  • Collaborated on Standard Operating Procedure (SOP) development, incorporating input from all teams to reduce liability and enhance successful deployments.

Analyst, Strategic Intel Analytics

Becton Dickinson
09.2021 - 04.2024
  • Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
  • Improved internal knowledge sharing by developing comprehensive documentation outlining standard operating procedures for various tasks.
  • Enhanced team collaboration by providing clear communication of complex findings through visualizations and reports.
  • Implemented predictive analytics techniques that enabled proactive adjustments to business strategies based on emerging trends.

Software Quality Engineer

Becton Dickinson
08.2016 - 09.2024
  • Facilitated improvements in overall software quality through active participation in process improvement initiatives within the organization.
  • Reduced defect rate by implementing robust test strategies and rigorous regression testing.
  • Developed test plans, test cases, and test scripts based on business requirements and functional specifications documents.
  • Ensured compliance with regulatory standards through diligent documentation of test results and procedures.
  • Improved software quality by conducting thorough testing and identifying bugs for timely resolution.

Education

Associate of Science - Computer And Information Systems

Southwestern College
Chula Vista, CA
06-2026

Skills

  • CAPA management
  • Equipment qualification
  • Process validation
  • Data integrity
  • Test method validation
  • Change control
  • Validation protocols
  • Computer system validation
  • Software validation
  • Quality management systems
  • ISO standards
  • Validation master plans
  • Risk assessment

Timeline

Computer Validation Specialst

Statera Consulting
04.2024 - Current

Analyst, Strategic Intel Analytics

Becton Dickinson
09.2021 - 04.2024

Software Quality Engineer

Becton Dickinson
08.2016 - 09.2024

Associate of Science - Computer And Information Systems

Southwestern College

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