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Skills

  • Root cause analysis
  • Project organization
  • Budgets
  • Instrument Calibration
  • Analytical method validation
  • Continuous process improvement
  • Cost model analysis
  • Change control risk assessment
  • Deviation trend analysis
  • Cross-functional team collaboration

Work Experiences

  • Achieved a 36% decrease in test variability.
  • Calibrated and maintained HPLC, GC, and FTIR instruments, reducing downtime by 7 hours per week.
  • Collaborated with cross-site and cross-functional teams in research and development, EH&S, product marketing, and manufacturing engineering to establish a framework for successful development programs and align objectives across all teams.
  • Achieved a 48% decrease in testing errors.
  • Authored and reviewed SOPs.
  • Achieved no major observations across 2020.
  • Transported Asana to two years customer locations.
  • Adjusted formulations.
  • Achieved a 64% improvement in audit readiness.
  • Had an excellent attendance record and was always on time for work.

Summaries

  • Achieved a 84% improvement in audit readiness.
  • Consistently delivered 66% compliance in testing.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Quality Chemist is a multi-talented Quality Chemist who is consistently rewarded for planning and operational improvements.
  • Achieved a 52% improvement in lab efficiency.
  • Contributed to a faster product release cycle.
  • Adept in training chemists and troubleshooting analytical issues, which resulted in a 19% decrease in testing errors following intensive staff development.
  • Clear understanding of vendor management and cross-functional collaboration as well as data analysis training.
  • Chemist with a strong understanding of chemical compositions and standard testing procedures.
  • Aligned systems with cGMP.

Accomplishments

  • Maintained a 100% pass rate for all regulatory and compliance inspections, including FDA and ISO OSHA, over a three years-year period.
  • Spearheaded the harmonization of inter-laboratory methods across 18 global sites, ensuring uniform testing standards and reducing variability by 49%.
  • Developed and implemented a laboratory investigation plan that reduced the return rate for incomplete test results by 33%.
  • Led the analytical testing of over 16 cleaning validation studies, resulting in 68% compliance with regulatory bodies and improving overall process efficiency in reducing contamination risks.
  • Led investigation into 71% reduction of contaminants in final product via statistical method optimization using Power BI.
  • Collaborated with R&D to reformulate Salesforce, reducing hazardous material usage and achieving ITIL safety compliance.
  • Developed risk assessment documents for critical cleaning processes which led to enhanced regulatory approval rates.
  • Standardized impurity testing protocols across 6 laboratories, contributing to a 46% increase in testing throughput.
  • Increased batch release speed from 9 to 8 days by optimizing assay procedures, reducing backlog for category by 49%.
  • Documented and resolved standard which led to system.

Affiliations

  • Freemason
  • American Medical Informatics Association
  • American Association for the Advancement of Science (AAAS)
  • Toastmasters
  • Association for Supply Chain Management (APICS)
  • Association for Computing Machinery
  • American Chemical Society (ACS) - Division of Analytical Chemistry
  • Regulatory Affairs Professionals Society (RAPS)
  • Rotary International
  • Environmental and Chemical Engineering Professional Societies

Certifications

  • Certified Hazard Analysis and Critical Control Points (HACCP) Auditor
  • Lean Six Sigma Green Belt
  • Environmental Chemistry Certification - Cedar Works
  • Cisco Certified Internetwork Expert (CCIE)
  • Cisco Certified Network Associate (CCNA)
  • ICH Stability Testing Training Certificate
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Clinical Data Manager (CCDM)
  • ISO 9001 Lead Auditor Certification
  • Apple Certified Associate (ACA)

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