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Skills

  • Change Management
  • Materials inspections
  • Continuous Improvement Initiatives
  • Time management
  • Lean manufacturing principles
  • Defect Tracking and Analysis
  • Communication of Quality Metrics
  • Data interpretation
  • Sampling protocols
  • Customer complaint resolution

Work Experiences

  • Oversaw testing procedures and ensured that tests were carried out in accordance with item specifications and protocol.
  • Authored and submitted technical reports to regulatory bodies, ensuring 100% compliance during surprise inspections.
  • Documented and executed detailed test plans and test cases, as well as summarized and logged audit findings for reporting purposes.
  • Achieved a 38% increase in operational efficiency.
  • Gathered and organized test data in preparation for the creation and analysis of reports.
  • Performed cell-based potency and impurity assays for in-process, release, and stability samples.
  • Analyzed materials, components, and products that were in the process of being made as well as those that were finished.
  • Coordinated bi-annual management reviews of the quality system, ensuring that business objectives were consistently aligned with quality outcomes.
  • Collaborated with cross-functional teams.
  • Achieved a 17% reduction in product waste.

Summaries

  • Ready to put 12 years of experience to work in order to meet program quality control goals.
  • Quality Systems Specialist is a multi-talented Quality Systems Specialist who is consistently rewarded for planning and operational improvements.
  • Achieved a 83% reduction in operational errors.
  • Bringing unrivaled technical troubleshooting and data interpretation expertise gained over 13 years of experience.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Completed multiple internal audits with a focus on cGMP compliance, reducing findings by 47% year after year and maintaining high industry standards.
  • Accomplished Quality Systems Specialist with expertise in validation protocols for new product launches, resulting in a 15% reduction of waste in the first 2020.
  • Assisted in product reliability improvements.
  • Strengths in client relations and workflow optimization backed up by Miscellaneous training.

Accomplishments

  • Managed the supplier audit program, increasing vendor qualification rates by 18% and lowering supply chain risks by 73%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Analyzed customer complaints and established a root-cause tracking system, reducing repeat complaints by 59%.
  • Resolved product issue through consumer testing.
  • Played a key role in the quality improvement team that implemented LEAN manufacturing principles, reducing waste and rework by 4%.
  • Developed validation protocols for critical equipment, achieving 100% compliance during FDA inspections with zero observations.
  • Partnered with suppliers and internal teams on non-conformance management, reducing rejected components by 10% within 18 months.
  • Conducted regular training sessions on ISO 9001:2015 compliance, contributing to 8% improvement in team adherence to quality policies.
  • Spearheaded quality training programs that led to 14 new hires being fully certified in ISO 9001:2015 requirements.
  • Instrumental in achieving zero findings in both internal and external quality audits through comprehensive readiness assessments.

Affiliations

  • Institute of Industrial and Systems Engineers (IISE)
  • Institute of Quality Assurance (IQA)
  • International Organization for Standardization (ISO) Expert Group
  • European Organization for Quality (EOQ)
  • Compliance and Risk Management Association (CRMA)
  • Society of Women Engineers
  • Association for Computing Machinery
  • Society of Quality Assurance (SQA)
  • Clinical and Laboratory Standards Institute (CLSI)
  • Parenteral Drug Association (PDA)

Certifications

  • Certified Pharmaceutical Industry Professional (CPIP) – Ironclad Systems, 2017
  • Root Cause Analysis and Corrective Action Certification Northwind 2016
  • Certified Manufacturing Engineer (CMfgE) Brightline - 2021
  • ISO 13485 Internal Auditor – Harbor & Co., 2024
  • Certified Business Analysis Professional (CBAP)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Public Accountant (CPA)
  • Certified Calibration Technician (CCT) Brightline
  • Certified Process Improvement Specialist (CPI) – Northwind, 2016
  • Project Management Professional (PMP)

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