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Skills

  • Cross-functional team collaboration
  • Continuous process improvement
  • Chromatography (HPLC/GC) expertise
  • Inventory and resource management in labs
  • Team building
  • Regulatory compliance
  • Laboratory safety protocol enforcement
  • Auditing and compliance monitoring
  • Implementation of new testing technologies
  • Operational budget forecasting

Work Experiences

  • Achieved results over a 2-month period.
  • Established the standards, practices, and procedures for the quality department.
  • Achieved Excellence Award for excellence in quality assurance leadership.
  • Organized and led quality review meetings to assess the effectiveness of performance in terms of risk mitigation, throughput improvement, and customer satisfaction.
  • Collaborated with cross-functional teams.
  • Achieved a 82% reduction in complaints.
  • Analyzed statistical control charts to identify trends that reduced production variability, lowering the standard deviation of key quality metrics by 15%.
  • Gathered, analyzed, and disseminated statistical data.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Used coaching tools and techniques to help managers and team members improve their performance.

Summaries

  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Achieved zero delays in production.
  • Carefully evaluated and refined testing protocols.
  • Experienced in reviewing and interpreting regulatory and programmatic guidance, as well as implementing corporate compliance, risk management, and corrective action programs.
  • Develop and maintain a quality management system that adheres to ISO 9001 and other relevant standards and business requirements.
  • Methodical Quality Assurance Manager with exceptional analytical and problem-solving skills.
  • Achieved a 34% reduction in deviations.
  • With extensive knowledge of Workday use, committed to high standards of product inspections and customer service.
  • Boosted overall testing efficiency by 32%.
  • Committed to evaluating product quality and manufacturing processes thoroughly in order to achieve superior results and customer satisfaction.

Accomplishments

  • Designed and implemented batch-release strategies based on Salesforce's critical quality attributes (CQAs), reducing variability by 73%.
  • Led stability testing for Adobe Creative Suite, identifying critical parameters that extended product viability by 8 months, helping reduce costs.
  • Resolved product issue through consumer testing.
  • Performed root cause analysis and corrective actions on production variances, improving overall product yield by 84%.
  • Documented and resolved metric which led to system.
  • Implemented quality by design (QbD) approaches for Salesforce, enhancing product formulation and leading to a 74% reduction in production errors.
  • Developed and executed validation protocols for new analytical techniques, achieving a 48% reduction in lead time for quality assessment.
  • Collaborated with team of 10 in the development of metric.
  • Contributed to the successful launch of metric by validating stability and degradation studies, supporting a 77% increase in product shelf-life.
  • Streamlined batch documentation review process, reducing turnaround time by 32%, ensuring timely product release into the market.

Affiliations

  • American Medical Informatics Association
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • The Chromatographic Society (ChromSoc)
  • Society of Chemical Industry (SCI)
  • American Association for the Advancement of Science (AAAS)
  • Toastmasters
  • Validation and Qualification Professionals Association (VQPA)
  • Certified Quality Auditor (CQA) – Issued by ASQ 2016
  • National Association of Social Workers
  • Institute of Packaging Professionals (IoPP)

Certifications

  • Occupational Safety and Health Administration (OSHA) Chemical Laboratory Safety
  • Certified Public Accountant (CPA)
  • Certified Hazardous Materials Manager (CHMM)
  • Job Hazard Analysis Training
  • Advanced Statistical Process Control (SPC) Techniques
  • Cisco Certified Internetwork Expert (CCIE)
  • SHRM Certified Professional (SHRM-CP)
  • Six Sigma Black Belt Certification
  • Project Management Professional (PMP)
  • First Aid/CPR Certified

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