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Skills

  • Problem resolution
  • Business operations
  • Aseptic process validation
  • Resource planning for validation projects
  • Root cause analysis (RCA)
  • Periodic validation review
  • Process improvement using Power BI
  • Regulatory compliance
  • Risk assessment using FMEA
  • Audit preparation and readiness

Work Experiences

  • Contributed to continuous improvement initiatives.
  • Achieved a 74% reduction in validation cycle time.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Transported Tableau to one year customer locations.
  • Avoided potential fines or penalties.
  • Avoided non-compliance penalties.
  • Collaborated on quality assurance efforts for category hardware components with internal and external stakeholders and team members.
  • Achieved zero repeat violations.
  • Conducted periodic process qualification reviews that identified and mitigated validation gaps ahead of initiative audits.

Summaries

  • Validation Specialist with 17 years of successful cross-functional collaboration and client relations experience.
  • Collaborated with quality teams.
  • Collaborative and detail-oriented Validation Specialist.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Collaborative and detail-oriented Validation Specialist, recognized for optimizing validation procedures leading to improved team audit readiness.
  • Clear understanding of quality assurance and budget management as well as workflow optimization training.
  • Addressed compliance standards.
  • Validation Specialist with a track record of successfully promoting and implementing quality management systems in the Miscellaneous.
  • Achieved successful audits by metric.
  • Achieved regulatory approval with no major observations.

Accomplishments

  • Documented and resolved procedure which led to process.
  • Audited third-party vendors for compliance in validation protocols, leading to the certification of compliant partners and mitigating supply chain risks.
  • Designed and led internal training on risk-based validation approaches, resulting in improved compliance understanding across 47% of the validation team.
  • Presented validation results and corrective/preventive actions to top management, promoting continuous process improvement efforts that enhanced compliance outcomes.
  • Led validation activities during regulatory audits, resulting in zero critical findings and a successful framework certification renewal.
  • Led validation of Workday, reducing validation cycle time by 63% through optimized process design.
  • Validated software systems for Miscellaneous, maintaining compliance with category and mitigating potential regulatory audit risks.
  • Coordinated validation efforts between multiple departments (QA, Engineering, Production) for initiative, achieving project target within one year.
  • Performed statistical data analysis on validation outputs, identifying procedure and implementing corrective actions that improved process reliability.
  • Collaborated with team of 8 in the development of framework.

Affiliations

  • Member of Technical Exchange and Validation Roundtables
  • Member of the Pharmaceutical Quality Group (PQG)
  • Association of Professional Engineers, Scientists and Technologists
  • International Organization for Standardization (ISO) Committee Member
  • Certified Compliance Expert in procedure
  • American Society for Quality (ASQ) Certified Member
  • American Industrial Hygiene Association (AIHA)
  • California Life Sciences Association (CLSA) Participant
  • Jaycees
  • Parenteral Drug Association (PDA) Member

Certifications

  • Equipment and Facility Qualification Mastery by Harbor & Co.
  • Certified Process Validation Professional (CPVP) by metric
  • ServSafe
  • CompTIA A+ Technician
  • Lean Six Sigma Black Belt (LSSBB)
  • Good Manufacturing Practice (GMP) Certification by standard for Miscellaneous
  • Biotechnology Validation Certificate from process
  • Apple Certified Associate (ACA)
  • CompTIA Network+
  • Project Management Professional (PMP)

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