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Skills

  • Precision measuring
  • Root cause analysis
  • Batch Record Documentation
  • Process optimization
  • Data analysis for production metrics
  • Relationship development
  • Organization
  • Equipment preventative maintenance
  • GMP Compliance
  • Team management

Work Experiences

  • Achieved a 45% reduction in contamination incidents.
  • Adhered to strict timelines.
  • Achieved zero errors during two years.
  • Collaborated cross-functionally with QC and R&D teams.
  • Assisted in validation processes during equipment upgrades.
  • Achieved an Top Performer.
  • Collaborated with R&D teams to transition a new drug from trial production to full-scale manufacturing, reducing production lead time by three years.
  • Achieved production levels of 49% above target.
  • Had an excellent attendance record and was always on time for work.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.

Summaries

  • Achieved 67% audit compliance.
  • General and preventive maintenance of process and support equipment is a strong suit.
  • Award-winning operations expert, recognized for maintaining production schedules and achieving zero reportable incidents over 3 accident-free days.
  • Chemical Operator with over 15 years of experience in the manufacturing industry.
  • Pharmaceutical Operator with 18 years of successful data analysis and project management experience.
  • Cut error rates by 63%.
  • Chemical Operator with experience using distributed control systems to control procedure processes and operate equipment.
  • Aligned production output needs with strategic maintenance efforts.
  • Adept at troubleshooting equipment issues.
  • Chemical Operator with demonstrated abilities in risk assessment and stakeholder engagement.

Accomplishments

  • Collaborated with team of 7 in the development of metric.
  • Ensured timely and accurate documentation of deviations during production, reducing deviation closure time by 72%.
  • Trained a team of 7 operators on precise API dosing methods, reducing batch rejections by 31% over 18 months.
  • Led a process optimization initiative that reduced cycle times by 25% while improving overall output quality.
  • Documented and resolved method which led to framework.
  • Identified and implemented opportunities for equipment improvements, resulting in a 75% increase in productivity over 2018.
  • Documented and reported weekly production metrics to senior management which improved operational decision-making and boosted efficiency by 50%.
  • Troubleshot and repaired complex automated control systems, improving uptime by 26% and reducing response times to errors.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Monitored and calibrated high-capacity pharmaceutical production equipment, ensuring compliance with procedure and achieving a 83% reduction in downtime.

Affiliations

  • International Pharmaceutical Excipient Council (IPEC)
  • International Academy of Compounding Pharmacists (IACP)
  • American Institute of Chemical Engineers (AIChE)
  • Council of Supply Chain Management Professionals (CSCMP)
  • Academy of Managed Care Pharmacy (AMCP)
  • American Society for Quality (ASQ)
  • Society for Biological Engineering (SBE)
  • Society for Industrial Microbiology and Biotechnology (SIMB)
  • BioPharma Research Council (BRC)
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)

Certifications

  • Certified Process Technician (CPT) awarded by Cedar Works
  • Advanced Certificate in Pharmaceutical Processing and Manufacturing from metric
  • Certified Risk Management Professional (CRMP) for Pharmaceutical Industry, awarded by Meridian
  • Good Manufacturing Practices (GMP) Certification, recognized by process
  • Certificate in Continuous Improvement and Kaizen Techniques for Pharma, by Cedar Works
  • Certified Public Accountant
  • Project Management Professional (PMP)
  • Hazard Analysis Critical Control Point (HACCP) Certification for Pharmaceutical Operators
  • Pharmaceutical Quality Control Certification, earned through Northwind
  • Google Certified Professional Cloud Architect

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