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Skills

  • Cross-functional team collaboration
  • Team building
  • MS Office
  • Operational improvement
  • Statistical analysis
  • FDA audit preparation and compliance
  • Media preparation and quality control
  • Lab equipment calibration and validation
  • Interdepartmental communication for QA alignment
  • RNA isolation knowledge

Work Experiences

  • Achieved a 10% reduction in testing bottlenecks.
  • Achieved 42% more accurate detection of low-level microbial contaminants.
  • Authored detailed microbiological analysis reports for regulatory submission, playing a key role in securing Employee of the Year from metric.
  • Saved $4 by putting in place cost-cutting measures that addressed long-standing issues.
  • Streamlined improved calibrator performance and production.
  • Achieved a 48% increase in detection of pathogenic organisms.
  • Helped with the production and testing of metric assays.
  • Collaborated with several teams on Biotechnology research.
  • Achieved a 56% reduction in batch contamination incidents.
  • Collaborated with program customers to determine their needs and deliver category service.

Summaries

  • Outstanding data management and report writing abilities that aid in research funding.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Achieved a 49% drop in contamination rates.
  • Authored comprehensive microbiology reports.
  • Contributed to FDA approval.
  • Costs were consistently reduced while profits were increased.
  • Scientist with a track record of establishing investigative tasks and motivating teams to achieve their objectives.
  • Within Biotechnology, senior Quality Control Microbiologist and outstanding performer in workflow optimization and stakeholder engagement.
  • Achieved sterility excellence.
  • Accelerated problem resolution.

Accomplishments

  • Successfully coordinated cross-functional teams during microbial excursions, implementing corrective and preventive actions (CAPA) within 18 months to mitigate contamination risks.
  • Spearheaded a continuous improvement project that aligned microbiology laboratory operations with Lean Six Sigma principles, optimizing test throughput by 76%.
  • Assisted in achieving industry compliance by revising Standard Operating Procedures (SOPs), which directly led to passing external audits with no major findings.
  • Monitored and documented all corrective actions from microbial contamination incidents, reducing future recurrence risk by 21% over the course of 2019.
  • Developed and led a lab-wide initiative that improved sterility testing throughput by 50%, while reducing error rates through process optimization.
  • Designed a comprehensive environmental monitoring program that resulted in a 62% reduction in microbial contamination over a period of one year.
  • Increased lab productivity by 22% through the introduction of automated systems for microbial enumeration and tracking.
  • Mediated between quality assurance and product development teams on microbiological specifications that enabled faster regulatory product approval at Summit Group.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Led a process improvement initiative in the laboratory that reduced equipment downtime for validation procedures by 22%.

Affiliations

  • Freemason
  • Association for Biosafety and Biosecurity
  • Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
  • Council for Laboratory Accreditation (COLA)
  • International Council of Nurses
  • International Organization for Standardization (ISO) Technical Committee for Microbiology
  • Lions Club
  • Jaycees
  • National Association of Social Workers
  • Good Manufacturing Practice (GMP) Education Program

Certifications

  • Lean Six Sigma Green Belt (LSSGB) - Ironclad Systems
  • Certified Contamination Control Specialist (CCCS) - Vantage
  • Certified Pharmaceutical Inspector (CPI) - Ironclad Systems
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Microbial Risk Assessment Certification - Harbor & Co.
  • CompTIA Network+
  • Advanced Statistical Process Control (SPC) Certification - HubSpot Training
  • SHRM Certified Professional (SHRM-CP)
  • Environmental Monitoring Specialist Certification - Summit Group
  • First Aid/CPR Certified

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