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Skills

  • Regulatory body interaction
  • Regulatory compliance with procedure
  • Biopharmaceutical aseptic processing
  • Equipment calibration and maintenance
  • Aseptic technique
  • Project organization
  • First Aid/CPR
  • Operational improvement
  • Contamination risk reduction
  • Equipment troubleshooting

Work Experiences

  • Achieved zero contamination events in 2023.
  • Conducted root cause analysis.
  • Achieved a 83% decrease in future deviations.
  • Adopted procedures across Chicago.
  • Achieved sterilization process goals through rigorous verification and validation of equipment and aseptic workflows, ensuring 19% compliance.
  • Achieved 3 consecutive successful audits.
  • Answered 2 calls per two years to help customers with their questions and concerns.
  • Transported ServiceNow to 6 months customer locations.
  • Had an excellent attendance record and was always on time for work.
  • Contributed to a 37% reduction in contamination risk.

Summaries

  • Committed to professional development by increasing treatment knowledge through hands-on learning.
  • Adept at collaborating with regulatory agencies during inspections, providing necessary documentation and maintaining operational compliance.
  • Collaborated with cross-functional teams to optimize root cause analysis, reducing downtime by 14 hours per batch and improving batch processing efficiency.
  • Ability to solve complex problems and maintain composure in stressful situations.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Adept in ensuring equipment calibration.
  • Comprehensive understanding of GMP.
  • Calibrated aseptic filling equipment.
  • Committed to providing consistent and focused attention to the safety, comfort, and dignity of our clients.
  • Conducted real-time monitoring.

Accomplishments

  • Created and maintained detailed records for all aseptic process deviations, contributing to 11 successful audits without major findings.
  • Played a key role in achieving production targets under sterile environments by identifying process inefficiencies ahead of time, boosting productivity by 50%.
  • Collaborated with cross-functional teams to monitor cleanroom conditions, preventing contamination events and ensuring compliance with regulatory standards.
  • Assisted in the alignment of environmental monitoring practices with current GMPs, resulting in 16% reduction in deviations during 2024 regulatory inspections.
  • Led daily monitoring of aseptic areas, preventing contamination by identifying early microbial growth in Microsoft Excel, reducing batch losses by 41%.
  • Contributed to operational excellence initiatives by identifying and implementing 13 process improvements within aseptic processing areas.
  • Performed routine environmental monitoring across manufacturing areas, consistently detecting deviations in real-time which reduced production delays by 61%.
  • Managed critical aseptic processing steps during the launch of Power BI, improving time to market and ensuring regulatory compliance.
  • Provided leadership in the identification of root causes for aseptic process deviations, successfully reducing investigation timelines by 7 days.
  • Resolved product issue through consumer testing.

Affiliations

  • American Society of Safety Professionals
  • International Association for Clean Air Industry (IACAI)
  • Society of Manufacturing Engineers (SME)
  • Cleanroom Management Certification – ServiceNow
  • Jaycees
  • Association for Computing Machinery
  • National Sterile Processing Association (NSPA)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • American Association of Pharmaceutical Scientists (AAPS)
  • Association for Supply Chain Management (APICS)

Certifications

  • Google Certified Professional Cloud Architect
  • FDA Aseptic Processing Certification
  • Certified Sterile Processing & Distribution Technician (CSPDT)
  • Salesforce
  • Lean Six Sigma Green Belt Certification
  • Certified Public Accountant (CPA)
  • Certified in the Principles of Aseptic Technique for Parenteral Products
  • Advanced Aseptic Technique Training
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Good Manufacturing Practice (GMP) Certification

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