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Skills

  • Organization
  • CCTV
  • Communications
  • 21 CFR Part 11 compliance
  • Equipment commissioning
  • Effective team collaboration with R&D
  • Knowledge of auditing systems
  • Quality assurance experience
  • Relationship development
  • Employee training

Work Experiences

  • Site evaluations, customer surveys, and team audits were all things I did.
  • Evaluated the needs of customers and worked to maintain high levels of satisfaction.
  • Boosted operational uptime by 70%.
  • Assessed industry trends.
  • Built a repository of validation documentation, reducing retrieval time for audits and inspections by 74%.
  • Authored risk assessments and coordinated qualification efforts, reducing product failure rates by 45%.
  • Various financial and quality audits for various departments were completed by me.
  • Achieved an Excellence Award for exceeding corporate quality goals.
  • Achieved compliance improvement within 2016.
  • Kept track of quality reports as well as statistical analyses.

Summaries

  • Proficient in promoting category by leveraging project management and stakeholder engagement knowledge.
  • Manager of Quality Assurance Validation with stakeholder engagement and quality assurance abilities.
  • Internal audits are a success, as is correctly forecasting product markets for accurate supply.
  • Strategic thinker with expertise in workflow optimization.
  • Achieved 50% improvement in output.
  • Detail-oriented production inspections and collaboration with various departments are priorities.
  • Manager of Quality Assurance Validation and team leader with 17 years of experience in metric settings.
  • QuickBooks and Asana experts with exceptional interpersonal skills.
  • Achieved 25% in enhanced operational uptime.
  • Looking forward to taking on a new challenge with a successful team.

Accomplishments

  • Trained cross-functional teams in Hazard Analysis and Critical Control Point (HACCP) methodologies, enhancing their validation acumen and compliance effectiveness.
  • Coordinated validation efforts with external regulatory audits, successfully achieving zero critical findings during audits conducted in 2017.
  • Developed vendor assessment protocols that led to the qualification of 9 new suppliers, improving material sourcing capabilities.
  • Successfully led validation strategies during Tableau launch, ensuring full compliance with procedure and bringing the product to market 7 weeks ahead of schedule.
  • Implemented continuous process improvement initiatives, reducing non-conformance events by 21% and showcasing operational efficiencies.
  • Directed cross-functional teams to validate HubSpot equipment, ultimately improving testing accuracy and productivity by 53%.
  • Introduced continuous validation workflows, reducing overall equipment downtime by 41%, while maintaining strict alignment with regulatory compliance.
  • Developed revalidation schedules for 3 manufacturing assets, leading to optimized resource use and decreased time-to-market by 75%.
  • Provided regulatory auditors with full documentation for validation efforts, leading to positive compliance ratings from Vantage.
  • Managed vendor qualification and audit processes, improving supplier reliability by 59% and reducing material rejections.

Affiliations

  • Frequent conference speaker for the Institute of Validation Technology (IVT), providing in-depth analysis on lean methodologies in the validation space.
  • Certified GMP Trainer through framework, specializing in the development of on-site validation training programs for manufacturing staff.
  • Volunteer Quality Systems Reviewer for the Association for the Advancement of Medical Instrumentation (AAMI), assisting in the development of validation guidelines.
  • Member of the FDA Quality Consortium, staying engaged with current and upcoming validation and process qualification regulation drafts.
  • Member of the American Society for Quality (ASQ), contributing to advancements in quality control and validation standards within the pharmaceutical industry.
  • Research contributor to ISPE’s Pharmaceutical Engineering journal, with a focus on cutting-edge enterprise resource planning (ERP) tools for validation management.
  • Quality Assurance and Validation Advisor for category, mentoring start-ups on regulatory compliance and FDA validation rules.
  • Alumni of procedure Validation and Compliance Program, retaining connections through industry-relevant educational and networking events.
  • Leader of cross-site task force for the Pharmaceutical Quality Group (PQG), standardizing performance qualification protocols globally.
  • Contributor to the Pharma Validation Board, sharing best practices in equipment, utilities, and process qualification.

Certifications

  • American Academy of Financial Management (AAFM)
  • Root Cause Analysis (RCA) Certification - from Summit Group
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Manufacturing Engineer (CMfgE) - from category
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE) from ASQ
  • Certified Pharmaceutical GMP Professional (CPGP) from ASQ
  • SHRM Certified Professional (SHRM-CP)
  • Certified Project Management for Regulatory Affairs (PRMRA) - from Harbor & Co.
  • Good Distribution Practices (GDP) Certification – from initiative
  • Cleanroom Management and Qualification Certification - from metric

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