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Skills

  • Quality assurance
  • ISO Lean Compliance
  • Collaboration with Engineering Teams
  • Communications
  • Supervision
  • Process improvement
  • Organization
  • Communication in high-pressure environments
  • Project organization
  • Product optimization

Work Experiences

  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Achieved results over 2 months.
  • Achieved a 66% compliance improvement.
  • Adhered to ISO PMP environmental control standards.
  • Adjusted process equipment controls to regulate liquid and gas pressure, temperature, and flow.
  • Achieved a 20% improvement in contamination control.
  • Adhered to industry standards.
  • Solved initiative issues, improved operations, and provided excellent customer service.
  • Transported Tableau to 18 months customer locations.
  • Created and connected efficient interfaces to handle 7 tasks at the same time.

Summaries

  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Achieved zero deviations during 2019.
  • Clean Room Operator is a multi-talented Clean Room Operator who is consistently rewarded for planning and operational improvements.
  • Adept at leading teams in cleanroom environments, achieving production goals and reducing operational waste by 48%.
  • Analyzed performance trends.
  • Within Miscellaneous, senior Clean Room Operator and outstanding performer in workflow optimization and data analysis.
  • Ready to contribute 9 years of experience to a dynamic role in a fast-paced environment.
  • Award-winning Clean Room Operator with a focus on contamination control and the ability to enhance overall efficiency by 66%.
  • Collaborated with cross-functional teams to ensure that all batch records were compliant with industry standards, minimizing audit findings.
  • Adhered to ISO OSHA standards.

Accomplishments

  • Provided hands-on training to 10 operators, focusing on GMP adherence and cleanroom best practices, which elevated team performance by 38%.
  • Coordinated in-spec audits for ISO Six Sigma recertification process, achieving 14% compliance on the first audit attempt.
  • Prepared and implemented CAPA plans that successfully addressed multiple regulatory findings, ensuring sustained internal compliance.
  • Resolved product issue through consumer testing.
  • Collaborated with team of 6 in the development of system.
  • Introduced compliance checklists for equipment sterilization, helping maintain ISO ITIL status during the 2020 audit period.
  • Successfully completed over 5 batch record verifications per shift, ensuring product release deadlines were consistently met without errors.
  • Maintained accuracy and completeness of logbooks, ensuring traceability for over 3 daily entries in compliance with FDA and EMEA regulations.
  • Led a cross-functional team response to contamination breach, restoring full production capacity within 3 hours and implementing preventive changes.
  • Implemented corrective actions following audit findings, successfully closing all CAPA reports within the past year, ensuring continuous production workflow.

Affiliations

  • Certified ISO Compliance Auditor - Cleanroom Specialization
  • Contributing Member of the Cleanroom Innovation Taskforce
  • Contamination Control Society (CCS)
  • Rotary International
  • Volunteer at Good Manufacturing Practices (GMP) Forum
  • Association for Computing Machinery
  • Cleanroom Technology Association (CTA)
  • American Medical Informatics Association
  • FDA-GMP Compliance Industrial Affiliation
  • American Society of Safety Professionals

Certifications

  • Certified Public Accountant
  • ServSafe
  • Salesforce
  • Certified Cleanroom Technician, Lakeside Partners, 2022
  • Project Management Professional (PMP)
  • OSHA Hazard Communication Standard (HCS) Certification
  • Environmental Monitoring Training Brightline
  • Lean Six Sigma Green Belt Certification
  • ISO 14644 Cleanroom Standards Certification
  • SHRM Certified Professional (SHRM-CP)

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