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Skills

  • Electronic records and signatures validation (ERES) under 21 CFR Part 11
  • International regulatory standards
  • Relationship development
  • New product validation strategy
  • System efficiency improvement of 64%
  • Budgets
  • Project organization
  • Risk assessment facilitation
  • Cross-site validation standardization
  • Compliance with FDA and ISO standards

Work Experiences

  • Collaborated with IT and data governance teams.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Authored detailed SOPs for validated equipment, ensuring consistent usage and maintenance, reducing downtime by 49%.
  • Authored detailed SOPs for validated equipment.
  • Collaborated with external vendors.
  • Collaborated with external vendors to ensure timely completion of equipment qualification, minimizing downtime and saving $18 annually.
  • Achieved Power BI market compliance in Portland.
  • Collaborated with IT and data governance teams to validate electronic recordkeeping systems as per 21 CFR Part 11, achieving CPA in 2020.
  • Achieved successful launch of operations.
  • Authored detailed validation documentation.

Summaries

  • Collaborates with developers to identify and fix issues prior to release.
  • Detail-oriented Validation Consultant with 16 years of Miscellaneous experience.
  • Achieved flawless inspection results consistently.
  • Validation Consultant is a multi-talented Validation Consultant who is consistently rewarded for planning and operational improvements.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Collaborated with quality assurance teams.
  • Validation Consultant with 17 years of successful risk assessment and budget management experience.
  • Reads and interprets technical documentation in order to make accurate software and functionality assessments.
  • Validation Consultant with a track record of successfully promoting and implementing quality management systems in the Miscellaneous.
  • Achieved successful market launches for Power BI.

Accomplishments

  • Documented and resolved framework which led to program.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Collaborated with team of 7 in the development of procedure.
  • Coordinated validation activities for new product launches, guaranteeing successful FDA approvals without delays or request for additional information.
  • Performed validation testing on new equipment that led to an overall reduction in down-time by 15%, while improving quality consistency.
  • Developed and executed performance qualification (PQ) protocols for Tableau, reducing human errors by 25% and minimizing resource wastage by $64,000.
  • Designed and implemented robust validation protocols that ensured Scrum Master compliance across QuickBooks, resulting in successful regulatory audits.
  • Liaised with cross-functional departments to implement validation processes and achieve project deliverables within one year despite shifting regulatory landscapes.
  • Successfully led efforts in automated system validations that streamlined operations and improved cost efficiency by 49%.
  • Managed a portfolio of validation projects worth $85,000, delivering all scheduled milestones ahead of one year.

Affiliations

  • American Medical Informatics Association
  • Verification and Validation Engineering Society (V&VES) - Active Participant
  • American Society of Safety Professionals
  • International GMP Academy (IGMPA) - GMP Certified since 2017
  • Society of Human Resource Management
  • Freemason
  • Controlled Release Society (CRS) - Expert Panel for Validation Protocols
  • Toastmasters
  • American Society of Mechanical Engineers (ASME) Member
  • Global Manufacturing and Validation Alliance (GMVA) - Co-Chair Annual Validation Summit 2015

Certifications

  • Certified Risk and Compliance Management Professional (CRCMP)
  • Certified Public Accountant (CPA)
  • Certified Cleanroom Professional (CCP) - Brightline
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE)
  • Computer System Validation (CSV) Lead Auditor Certification
  • First Aid/CPR Certified
  • Certified Six Sigma Black Belt (CSSBB)
  • Salesforce
  • Medical Device GMP Certification - Brightline
  • CLSI Medical Laboratory Validation Certification

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