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Skills

  • Risk mitigation in validation projects
  • Risk-based validation approach development
  • Audit preparation and execution
  • Cross-functional project leadership
  • Test implementation
  • Data integrity compliance
  • Problem resolution
  • Operational improvement
  • Method equipment
  • Regulatory compliance

Work Experiences

  • Aligned validation activities.
  • Authored a comprehensive validation plan for Power BI.
  • Contributed to attaining OSHA within deadline.
  • Co-authored risk assessments for high-impact validation projects, mitigating risks that could delay product release.
  • Achieved certification within 5 months.
  • Created risk-based validation approaches that cut costs by $14 while maintaining compliance and quality deliverables.
  • Coordinated pre-validation audits.
  • Addressed queries about validation approaches.
  • Collaborated with global sites to align validation activities, resulting in 8% reduction in duplication of effort.
  • Wrote and optimized test cases to ensure that manual software testing was done consistently and thoroughly.

Summaries

  • Strong manual and automation testing experience.
  • Collaborated with third-party vendors.
  • Asana expert and QuickBooks user.
  • Achieved President's Club recognition.
  • Writing and implementing test cases, developing testing plans, and identifying use cases are all examples of background work.
  • Automated validation procedures.
  • Accomplished Senior Validation Consultant.
  • Accomplished Senior Validation Consultant skilled in the development and execution of validation protocols, risk-based approaches, and ensuring compliance with FDA, ISO, and GxP standards, resulting in faster time-to-market.
  • Collaborative leader focused on aligning validation deliverables.
  • Achieved a 38% improvement in validation consistency.

Accomplishments

  • Collaborated with stakeholders across 4 departments to design validation protocols that shortened the approval process by 8 days.
  • Authored and reviewed validation reports, ensuring documentation met regulatory expectations for the West Coast, resulting in 79% quicker regulatory approval.
  • Successfully conducted process validations for Microsoft Excel, eliminating 6 recurring issues that had previously delayed the project.
  • Executed equipment qualification for Salesforce, ensuring flawless integration of validation data into regulatory reporting systems.
  • Trained 6 cross-functional team members on new CAPA processes, reducing CAPA resolution times by 42%.
  • Conducted root cause analysis on stakeholder engagement failures, enabling key process improvements that improved reproducibility by 41%.
  • Created robust validation timelines and milestones, accelerating the project schedule by 18% over the course of 2019.
  • Implemented an automated validation process for Asana, reducing human errors and non-compliance issues by 40%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Managed validation efforts during a product recall, leading the team in implementing CAPAs that closed 17 audit findings.

Affiliations

  • Freemason
  • Association for Computing Machinery
  • Controlled Release Society (CRS) - Engaged in validation of time-release drug protocols
  • Pharmaceutical and Medical Device Compliance Congress - Participant, focusing on validation lifecycle management
  • International Society for Pharmaceutical Engineering (ISPE) - Member since 2022
  • FDA Global Conference on Global Validation Practices - Participant, Networker
  • Validation and Verification Special Interest Group (SIG) - Contributor to validation protocol enhancements
  • Lions Club
  • Toastmasters
  • Rotary International

Certifications

  • Salesforce
  • Certified Quality Systems Specialist (CQSS) – 2016 Beacon Labs
  • Certified Professional in Healthcare Quality (CPHQ) 2017
  • Certified Change Control Specialist (CCCS) – 2019 framework
  • Google Certified Professional Cloud Architect
  • Certified Quality Improvement Associate (CQIA) – 2024 standard
  • Certified Quality Auditor (CQA) 2018 – Harbor & Co.
  • Risk Management Professional (PMI-RMP) – 2022 standard
  • ServSafe
  • CompTIA Security+

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