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Skills

  • Equipment qualification (IQ/OQ/PQ)
  • ISO 9001 compliance
  • Conflict resolution in team settings
  • Bachelor's/Master's degree in Chemistry/Biology
  • Communications
  • Testing procedures
  • Business operations
  • Data interpretation
  • Cost Reduction through Process Optimization
  • Data-driven decision making

Work Experiences

  • Authored detailed technical reports for batch releases, significantly reducing approval delays by 15 days.
  • Investigated test results that appeared to be suspect.
  • Conducted a visual inspection of products to determine if they met quality standards.
  • Technical documents such as deviation reports, testing protocols, and trend analyses were all written by me.
  • Achieved Innovation Award.
  • Performed cell-based potency and impurity assays for in-process, release, and stability samples.
  • Completed data capture forms, equipment logbooks, and inventory forms as part of the testing procedures documentation.
  • Collaborated with supply chain teams to perform incoming inspections and root cause analysis of defective materials, preventing 32% future defects.
  • Collaborated with supply chain teams.
  • Analyzed product performance metrics.

Summaries

  • Disciplined professional who approaches cross-functional collaboration in a systematic manner.
  • Advanced skills in chromatography and spectrophotometry, ensuring that products consistently meet required specifications and quality standards in HubSpot.
  • Extensive testing of incoming materials, components, and finished products is second nature to me.
  • Quality Control Analyst with experience testing HubSpot and Miscellaneous products.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Aligned quality and production goals.
  • Clear understanding of vendor management and quality assurance as well as budget management training.
  • Accomplished Quality Control Scientist with a proven track record of conducting thorough trend analysis and presenting actionable insights that resulted in $11 in cost savings.
  • Advanced skills in spectrophotometry.
  • Costs were consistently reduced while profits were increased.

Accomplishments

  • Streamlined microbiological testing processes, enhancing laboratory capacity by 41% and reducing the average testing time by 7 days.
  • Developed and introduced a new sampling methodology that lowered testing time by 50% while exceeding ITIL quality standards for repeatability.
  • Reduced equipment downtime in the QC lab by 17% through the introduction of preventive maintenance procedures for critical instruments.
  • Authored detailed reports for root-cause analysis and remediation steps, reducing future deviations and leading the QC team to a 22% error reduction.
  • Led weekly cross-departmental meetings, ensuring alignment on quality standards and reducing production downtime by 19%.
  • Spearheaded the introduction of method, reducing the defect rate by 20% and improving overall product reliability.
  • Implemented corrective actions based on deviation investigations, resulting in a 29% decrease in non-conformance incidents over a two years period.
  • Implemented Lean Six Sigma strategies across QC workflows, which reduced overall cost of quality by 54%, enhancing profitability.
  • Collaborated with process engineers to achieve Scrum Master certification through a thorough audit of quality processes and procedural updates.
  • Collaborated with team of 7 in the development of program.

Affiliations

  • Association for Supply Chain Management (APICS)
  • American Industrial Hygiene Association (AIHA)
  • Parenteral Drug Association (PDA)
  • International Society for Pharmaceutical Engineering (ISPE)
  • American Medical Informatics Association
  • Center for Drug Evaluation and Research (CDER) Collaborative Group
  • Global Compliance Product Support Forum
  • European Compliance Academy (ECA)
  • National Institute of Standards and Technology (NIST) Collaboration Group
  • International Council of Nurses

Certifications

  • SHRM Certified Professional (SHRM-CP)
  • CompTIA Security+
  • Good Automated Manufacturing Practice (GAMP) Certification – Meridian
  • Risk Management Training – Lakeside Partners
  • Project Management Professional (PMP)
  • Environmental Monitoring Certification - Harbor & Co.
  • Lean Manufacturing Certification - Brightline
  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Quality Engineer (CQE) - American Society for Quality (ASQ)
  • Computer System Validation (CSV) Certification – Lakeside Partners

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