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Skills

  • Organization
  • Audit preparation and management
  • Communications
  • Chemical engineering
  • Contamination prevention measures
  • Lean manufacturing processes
  • Preventive maintenance scheduling
  • CIP (Cleaning-In-Place) and SIP (Sterilization-In-Place)
  • Batch record review
  • Production planning

Work Experiences

  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Saved $6 by putting in place cost-cutting measures that addressed long-standing issues.
  • Conducted root cause analysis of batch inconsistencies, implementing corrective measures that improved batch yield by 44%.
  • Collaborated with R&D on piloting new production processes, facilitating the launch of Tableau which resulted in a 5% rise in initial market share.
  • Contributed to the development of corrective action plans post-audit that resulted in process improvements and achieving Lean by 2018.
  • Adjusted equipment settings during production runs.
  • Looked for industry trends on social media and through online sources.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved 34% compliance with prescribed standards.
  • Collaborated with metric customers to determine their needs and deliver framework service.

Summaries

  • Adept at batch record reviews and ensuring full traceability of manufacturing processes, maintaining audit readiness for Lean with zero deviations.
  • Pharmaceutical Manufacturing Operator is a multi-talented Pharmaceutical Manufacturing Operator who is consistently rewarded for planning and operational improvements.
  • Achieved 46% improvement in team performance.
  • Expert at inspecting machinery for leaks and malfunctions.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Adhered to rigorous safety and quality standards.
  • Achieved a 35% reduction in cycle time.
  • Achievement-oriented in cross-functional team environments.
  • With over 5 years of Miscellaneous experience, I am meticulous and detail-oriented.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.

Accomplishments

  • Documented and resolved procedure which led to program.
  • Authored and updated Standard Operating Procedures (SOPs), reducing deviation occurrences by 75% and ensuring adherence to FDA and internal standards.
  • Helped implement Total Productive Maintenance (TPM) initiatives to extend equipment lifespan and reduce unplanned downtime by 59%.
  • Utilized ERP and MES systems to manage work order execution and materials tracking with no scheduling conflicts, improving batch record traceability.
  • Collaborated with engineering on the implementation of continuous improvement projects, reducing material waste by 33% per batch.
  • Trained and mentored new hires on capsule and tablet formulation techniques, improving operational readiness and reducing onboarding time by 16 weeks.
  • Implemented process improvements resulting in a 33% increase in overall yields for SAP, contributing to a successful process inspection.
  • Designed and deployed a process control strategy that reduced variation in batch production times and increased overall product consistency.
  • Executed and documented high-volume tablet press and capsule-filling operations, consistently meeting daily production quotas and quality thresholds.
  • Spearheaded a team initiative to decrease calibration time for critical production equipment, achieving an 33% improvement in overall calibration cycle time.

Affiliations

  • Member of the American Chemical Society (ACS), division of Medicinal Chemistry
  • Certification in Sterile Manufacturing from method
  • Participated in ISPE Pharmaceutical Manufacturing Facilities and Engineering workshops
  • Affiliated with the European Federation for Pharmaceutical Sciences (EUFEPS)
  • American Association of Pharmaceutical Scientists (AAPS)
  • Attended annual Biomedical Engineering Society (BMES) Conference
  • Completed advanced training through the Bio-Process Systems Alliance (BPSA)
  • American Society of Safety Professionals
  • Association for Women in Pharmaceutical Sciences
  • American Marketing Association

Certifications

  • Certified Public Accountant
  • Certified Pharmaceutical Manufacturing Operator (CPMO) - Vantage, 2021
  • FDA Process Validation Certification - Cedar Works, 2019
  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Occupational Safety Specialist (COSS) - Beacon Labs 2020
  • Certified in EudraLex GMP Guidelines - Summit Group, 2022
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA A+ Technician
  • LEAN Manufacturing Certification for Pharmaceutical Production - Northwind, 2024
  • Data Integrity Compliance Certification - ServiceNow, 2017

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