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Skills

  • Supervision
  • Advanced statistical analysis for quality control
  • Laboratory safety protocol enforcement
  • Environmental contamination control
  • Regulatory compliance
  • Project organization
  • Inventory and resource management in labs
  • Asana expert
  • ISO certification process management
  • Risk assessment and mitigation

Work Experiences

  • Worked with audit clients and action owners to implement root cause analysis recommendations and create effective corrective action plans.
  • Authored and presented 4 technical investigation reports to management, which led to the decision to enhance our testing facility with category.
  • Analyzed results from advanced chromatographic techniques.
  • Established and tracked the goals and objectives of the quality department.
  • Achieved a 82% reduction in complaints.
  • Achieved a failure rate of less than 61%.
  • Analyzed statistical control charts to identify trends that reduced production variability, lowering the standard deviation of key quality metrics by 15%.
  • Assessed Asana quality.
  • Looked for industry trends on social media and through online sources.
  • Transported HubSpot to 18 months customer locations.

Summaries

  • Methodical Quality Assurance Manager with exceptional analytical and problem-solving skills.
  • Boosted overall testing efficiency by 32%.
  • Develop and maintain a quality management system that adheres to ISO 9001 and other relevant standards and business requirements.
  • Costs were consistently reduced while profits were increased.
  • Operational improvements, program implementation, and documentation are among his specialties.
  • Manage a quality audit program to identify and correct nonconformities, as well as to instill a culture of continuous improvement.
  • Achieved a 16% reduction in contaminant levels.
  • Boosted testing efficiency by 42%.
  • Exceptional at spotting flaws and initiating solutions to problems.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.

Accomplishments

  • Reduced product batch release times by 73% through process optimization and tighter coordination between quality and operations teams.
  • Executed QC protocol reviews and updates, resulting in a 52% increase in compliance during internal audits.
  • Reviewed and approved batch production records, ensuring compliance with GMP and product releases, resulting in zero regulatory findings during 2020's audit.
  • Designed and implemented batch-release strategies based on Salesforce's critical quality attributes (CQAs), reducing variability by 73%.
  • Conducted internal audits to ensure adherence to FDA, ISO, and cGMP quality systems, achieving a 53% improvement in overall regulatory compliance ratings.
  • Performed analytical testing on raw materials and finished goods, ensuring product specifications were met 100% of the time.
  • Optimized lab workflows in alignment with Lean Six Sigma methodologies, reducing testing redundancies and achieving a 51% increase in throughput.
  • Resolved product issue through consumer testing.
  • Authored and revised 7 SOPs, resulting in enhanced safety adherence and regulatory compliance, reducing the accident rate by 44%.
  • Led the investigation and resolution of out-of-specification (OOS) results, reducing batch rejection rates by 58% over a the past year.

Affiliations

  • Toastmasters
  • Certified Quality Auditor (CQA) – Issued by ASQ 2016
  • Rotary International
  • Society of Human Resource Management
  • International Association for Food Protection (IAFP)
  • International Society for Quality in Health Care (ISQua)
  • International Pharmaceutical Federation (FIP)
  • American Marketing Association
  • The Royal Society of Chemistry (RSC)
  • Sigma Xi, The Scientific Research Honor Society

Certifications

  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Public Accountant (CPA)
  • Occupational Safety and Health Administration (OSHA) Chemical Laboratory Safety
  • ASQ Certified Quality Engineer (CQE)
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Quality Inspector (CQI)
  • Certified Business Analysis Professional (CBAP)
  • Certified Process Safety Auditor (CPSA)
  • Advanced HPLC Training Certification
  • FDA Process Validation Training

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