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Skills

  • Relationship development
  • Business process improvement
  • Occupational safety adherence (OSHA)
  • Operational improvement
  • Lean manufacturing principles
  • MS Office
  • Downtime reduction strategies
  • Document control and record-keeping
  • Adverse event reporting (AER)
  • Production planning

Work Experiences

  • Contributed to passing category with zero non-conformances.
  • Conducted system audits.
  • Avoided 6 hours of downtime.
  • Collaborated with cross-functional teams.
  • Achieved compliance.
  • Achieved 34% compliance with prescribed standards.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Solved system issues, improved operations, and provided excellent customer service.
  • Adjusted environmental monitoring systems for compliance.
  • Developed training manuals and conducted workshops on proper equipment handling, improving adherence to SOPs and reducing errors by 74%.

Summaries

  • Adept at batch record reviews.
  • With over 5 years of Miscellaneous experience, I am meticulous and detail-oriented.
  • Achieved this over three years.
  • Calibrated equipment effectively.
  • Achieved zero non-conformances.
  • Achieved a 8% increase in market share.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Achieved $14 in annual savings.
  • Adhered to rigorous safety and quality standards.
  • Pharmaceutical Manufacturing Operator is a multi-talented Pharmaceutical Manufacturing Operator who is consistently rewarded for planning and operational improvements.

Accomplishments

  • Collaborated with the Quality Assurance team to successfully pass 17 consecutive audits with zero critical findings from regulatory bodies such as the FDA and program.
  • Collaborated with team of 3 in the development of procedure.
  • Resolved product issue through consumer testing.
  • Utilized ERP and MES systems to manage work order execution and materials tracking with no scheduling conflicts, improving batch record traceability.
  • Participated in Lean Six Sigma project focusing on reducing cycle times and waste generation, resulting in year-over-year savings of $9.
  • Developed cleaning validation protocols, ensuring regulatory compliance for multi-product manufacturing lines and reducing cross-contamination risks.
  • Helped implement Total Productive Maintenance (TPM) initiatives to extend equipment lifespan and reduce unplanned downtime by 59%.
  • Effectively performed in-process testing during tablet and capsule manufacturing to ensure batch compliance with FDA/ISO OSHA standards.
  • Worked closely with quality control engineers to troubleshoot equipment malfunctions, minimizing production stoppages and keeping downtime below 14 hours per week on average.
  • Trained and mentored new hires on capsule and tablet formulation techniques, improving operational readiness and reducing onboarding time by 16 weeks.

Affiliations

  • Certificate in FDA Regulations for Pharmaceuticals through category
  • Project Management Institute
  • Certified in Good Manufacturing Practice (GMP) by procedure
  • American Medical Informatics Association
  • International Society for Pharmaceutical Engineering (ISPE)
  • Active member of FDA Inspections Readiness Working Group
  • International Association of Administrative Professionals
  • Professional Membership in Regulatory Affairs Professionals Society (RAPS)
  • National Association of Social Workers
  • Lions Club

Certifications

  • Microsoft Certified Systems Engineer (MCSE)
  • CompTIA Security+
  • Process Validation Professional Certification - Summit Group, 2016
  • Certified Industrial Hygiene Manager (CIHM) - Meridian, 2017
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Apple Certified Associate (ACA)
  • FDA Process Validation Certification - Cedar Works, 2019
  • Certified Quality Auditor (CQA) – standard
  • OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER) Certification - 2022
  • Certified Public Accountant

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