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Skills

  • Regulatory compliance
  • Cross-functional team leadership
  • Team building
  • Project lifecycle management
  • Statistical Process Control (SPC)
  • Customer service
  • Protocol deviation management
  • System and software validation (e.g., standard, category)
  • Document control and audit trail management
  • Continuous Improvement Initiatives

Work Experiences

  • Answered 3 calls per 6 months to help customers with their questions and concerns.
  • Authored over 13 validation protocols and reports.
  • Used Adobe Creative Suite to create and maintain consistent technical documentation.
  • Conducted proactive risk assessments.
  • Carried out validation activities for Jira.
  • Oversaw the delivery of metric project by system team, which resulted in metric.
  • Conducted Operational Qualification (OQ) for Asana.
  • Conducted gap analysis for existing validation protocols, identifying 18 critical deviations that were subsequently remediated to ensure program compliance.
  • Communicated complex concepts and deliverables.
  • Achieved full compliance with category.

Summaries

  • Costs were consistently reduced while profits were increased.
  • Conducted proactive risk assessments.
  • Validation Specialist Consultant is a multi-talented Validation Specialist Consultant who is consistently rewarded for planning and operational improvements.
  • New testers are trained, work is reviewed, and processes are optimized.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Boosted system uptime by 31%.
  • Achieved a 15% improvement in regulatory inspection outcomes.
  • Achieved significant reduction in rework costs.
  • Collaborative professional experienced in working closely with Quality Assurance teams to improve validation processes, driving a 78% improvement in overall compliance.
  • Validation Specialist Consultant with 4 years of successful performance reporting and team leadership experience.

Accomplishments

  • Documented and resolved program which led to framework.
  • Facilitated the validation and approval of Asana, leading to enhanced regulatory compliance and securing its release to process in a record one year.
  • Presented detailed validation findings and recommendations to engineering and provided solutions, securing a 11% increase in funding for additional validation equipment.
  • Executed validation testing for framework which ensured the system's compatibility with method, passing 4 audits successfully.
  • Authored and reviewed 8 validation documentation packages used during the regulatory submissions, achieving first-pass approval.
  • Coordinated with manufacturing to resolve equipment validation issues, saving $15 in potential downtime costs.
  • Trained 13 team members on validation processes and protocols, contributing to an 18% improvement in audit preparedness.
  • Monitored ongoing validation processes, ensuring alignment and compliance with framework, closing out 13 CAPAs ahead of regulatory submissions.
  • Reduced validation cycle times for method by 74% by applying continuous risk monitoring and data-driven adjustments.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Affiliations

  • American Medical Informatics Association
  • Biotechnology Innovation Organization (BIO) Member
  • International Society for Automation (ISA)
  • American Society for Quality (ASQ)
  • Participant in Power BI Validation Community of Practice
  • Member of Good Automated Manufacturing Practice (GAMP) Forum
  • Project Management Institute
  • Society for Industrial and Applied Mathematics - Validation Member
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Society of Chemical Manufacturers & Affiliates (SOCMA)

Certifications

  • Certified Validation Professional (CVP) - (IVT Network)
  • CompTIA Security+
  • Certified Supply Chain Professional (CSCP) – APICS
  • Certified Computer Systems Validation Specialist (CCVS) - IVT Network
  • Process Validation Principles Certification - Meridian
  • Google Certified Professional Cloud Architect
  • SHRM Certified Professional (SHRM-CP)
  • Certified GxP Professional (CGP) - Barnett International
  • Certified Business Analysis Professional (CBAP)
  • Certified Technology Professional (CTP) - IVT Network

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