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Skills

  • Equipment validation
  • Budgets
  • ISO 13485 standards
  • Quality assurance collaboration
  • Deviation analysis
  • Test implementation
  • Interpersonal communication skills
  • Defect monitoring
  • Business operations
  • GMP (Good Manufacturing Practices)

Work Experiences

  • Authored risk-based validation protocols that incorporated statistical sampling, resulting in reduced total testing efforts by 72%.
  • Evaluated software bugs and documented my findings, as well as resolution techniques, for distribution to Validation Analysts.
  • Completed revalidation processes for legacy systems within the stipulated 18 months, ensuring no interruptions in production cycles.
  • Decreased audit findings.
  • Designed a new tracking system for validation statuses, resulting in a the past year% faster identification of out-of-specification equipment.
  • Contributed to a Top Performer project, validating processes that sped product release while ensuring regulatory compliance on all fronts.
  • Conducted final validation testing for launch of Adobe Creative Suite.
  • Achieved zero critical defects post-launch.
  • Developed and executed validation test protocols for ServiceNow, ensuring compliance with FDA and ISO standards.
  • Conducted final validation testing for launch of Jira, resulting in zero critical defects post-launch across 3 sites.

Summaries

  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Addressed non-conformance issues.
  • Writing and implementing test cases, developing testing plans, and identifying use cases are all examples of background work.
  • Boosted team efficiency.
  • Collaborated with cross-functional teams.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Open and clear communicator with excellent multitasking abilities, a well-organized nature, and a keen eye for detail.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Clear understanding of cross-functional collaboration and process improvement as well as risk assessment training.

Accomplishments

  • Documented and resolved procedure which led to standard.
  • Collaborated with external auditors to present validation results, resulting in 13 consecutive years of successful compliance with zero findings.
  • Produced validation test cases for new software systems, reducing post-launch issues by 37% within 18 months.
  • Created a comprehensive validation master plan covering metric's compliance measures and addressing all category requirements.
  • Executed pFMEA across critical system components, preventing 14 potential process failures and maintaining compliant operations.
  • Collaborated with team of 12 in the development of framework.
  • Implemented process validation on initiative production equipment, achieving a 50% improvement in product quality and reducing manufacturing defects.
  • Designed validation protocols that achieved full compliance with method, avoiding potential penalties and $99,000 in fines.
  • Executed cleaning validation studies for system, ensuring compliance with FDA requirements and reducing potential contamination risks.
  • Resolved product issue through consumer testing.

Affiliations

  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Lean Six Sigma Green Belt Certification
  • Master in Pharmaceutical Validation Certification (MPVC)
  • International Association of Administrative Professionals
  • Validation Technology Certification Program (VTCP)
  • Association for Supply Chain Management (APICS)
  • American Society for Quality (ASQ)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Project Management Institute
  • Association of Information Technology Professionals

Certifications

  • Triggered Change Control Expert Program - Northwind
  • Operational Excellence Professional (OPEX) Certification - 2018
  • Certified Packaging Professional (CPP) - standard
  • Certified ISO 13485:2016 Lead Auditor - Lakeside Partners 2020
  • Project Management Professional (PMP)
  • Validation Lifecycle Management Process (VLMP) Certification - process 2022
  • SHRM Certified Professional (SHRM-CP)
  • Risk Management Professional (RMP) Certification - 2023
  • Certified Business Analysis Professional (CBAP)
  • Lean Six Sigma Black Belt - program 2018

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