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Skills

  • Business operations
  • Process improvement strategies
  • Team building
  • Equipment qualification (IQ/OQ/PQ)
  • Relationship development
  • Standard operating procedure (SOP) development
  • Audit readiness and process improvement
  • Revalidation process execution
  • CAPA implementation follow-up and tracking
  • Communications

Work Experiences

  • Authored validation master plans for initiative, ensuring that validation governance was aligned with corporate and regulatory goals.
  • Transported Adobe Creative Suite to three years customer locations.
  • Developed and monitored key performance indicators (KPIs) for the validation department, driving an 27% increase in operational efficiency.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Achieved $2 annual savings.
  • Answered 16 calls per one year to help customers with their questions and concerns.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Collaborated with the QA department.
  • Co-authored corporate guidelines for validation management, standardizing best practices across Austin sites.
  • Achieved a 75% improvement in efficiency.

Summaries

  • Contributed to improved operational flow.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Achieved no significant observations or corrective actions.
  • Aligned validation protocols with the latest industry regulations.
  • Ability to document and write reports in a professional manner.
  • Senior Validation Specialist with experience writing manual and automated test cases and scripts.
  • Adept Senior Validation Specialist specializing in corrective and preventive actions. Successfully implemented CAPAs that reduced recurring issues by 17%, ensuring smooth continuous operations for metric.
  • Leading onsite and offshore quality assurance teams to evaluate the full functionality and individual modules of standard programs is a strong suit.
  • Balanced robust compliance standards with efficient project execution.
  • Consistently drove efficiencies through well-planned validation protocols.

Accomplishments

  • Partnered with suppliers to implement more robust validation protocols, reducing overall vendor validation times by 3 days in 2024.
  • Documented and resolved process which led to initiative.
  • Designed and conducted a Process Performance Qualification (PPQ) for system, meeting both FDA and method standards.
  • Collaborated with cross-functional teams from engineering, manufacturing, and QA to develop harmonized validation procedures, resulting in a 62% increase in process efficiency.
  • Successfully implemented CAPA measures for recurring validation failures, leading to a 43% reduction in similar non-compliance events.
  • Served as the primary lead for validation efforts during category expansion, ensuring timely completion of all documentation and protocol execution.
  • Directed FAT/SAT activities for key equipment installations, validating against initiative requirements and reducing installation time by 80%.
  • Collaborated with team of 7 in the development of standard.
  • Enhanced overall product quality and compliance by conducting robust qualification testing in line with process.
  • Implemented automated validation documentation systems, decreasing manual error rates by 66% and improving data traceability.

Affiliations

  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Association for Supply Chain Management (APICS)
  • International Council of Nurses
  • Rotary International
  • International Council for Harmonization (ICH)
  • American Institute of Chemical Engineers (AIChE)
  • Pharmaceutical Compliance Forum
  • Institute of Validation Technology (IVT)
  • Parenteral Drug Association (PDA)
  • Medical Device Innovation Consortium (MDIC)

Certifications

  • Certified Specialist in Regulatory Compliance (SRC) – 2019, Brightline
  • CompTIA Network+
  • Cisco Certified Network Associate (CCNA)
  • Good Manufacturing Practices (GMP) Certification – 2021, NSF International
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Packaging Machinery Professional (CPMP) – 2022, Institute of Packaging Professionals
  • CompTIA A+ Technician
  • Good Laboratory Practice (GLP) Certification – 2020, Harbor & Co.
  • Project Management Professional (PMP)
  • Certified Pharmaceutical Regulatory Affairs Professional (CPRA) – 2020, Beacon Labs

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