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Skills

  • Quality Control Testing
  • Team building
  • Laboratory computer systems
  • Communication and Interpersonal Skills
  • Security systems
  • Statistical analysis
  • Materials testing
  • Risk mitigation
  • RFI Scanners
  • Customer complaint investigation

Work Experiences

  • Was in charge of all tasks delegated to me, including data analysis and risk assessment.
  • Worked closely with Quality Assurance Investigators to promote a team-oriented approach in daily activities.
  • Achieved annual savings of $7.
  • Achieved 16% improvement in quality issue resolution times.
  • Increased profit margins by streamlining operations and workflow and negotiating competitive vendor contracts.
  • Achieved process optimization in Atlanta.
  • Used Jira to run test scripts to compare specifications and ensure that they met customer requirements.
  • Achieved a compliance increase of 50%.
  • Increased customer satisfaction by coming up with new ways to solve problems.
  • Achieved approval with no deficiencies.

Summaries

  • Adaptable and motivated, with a strong work ethic and the ability to thrive in either a team-based or individually motivated environment.
  • Team leadership in category settings and team leadership in stakeholder engagement settings.
  • With hands-on experience, eager to learn new skills and advance knowledge.
  • Strategic thinker with expertise in data analysis.
  • Expert in system with a strong aptitude for improved and implemented.
  • Accomplished at ensuring regulatory compliance, successfully reducing operational nonconformance rates by 36% through targeted root cause analyses and cross-functional team efforts.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Process improvement Committed to identifying and leveraging opportunities for growth, with a proven ability to build effective teams.
  • Inspections of framework and mentoring others are two of my specialties.
  • Quality Assurance Investigator and team leader with 9 years of experience in category settings.

Accomplishments

  • Assisted with the preparation for process, achieving a pass with no major findings, sustaining the company's compliance history for procedure years.
  • Implemented structured communication channels between Quality and Production teams, reducing defect report processing times by 71%.
  • Executed regular risk assessments on equipment and operational processes, proactively identifying areas of improvement that enhanced compliance with CPA.
  • Led internal audits in alignment with OSHA standards, identifying non-conformance trends and driving process improvements that led to a 21% decrease in audit findings.
  • Acted as the primary liaison with external auditors during program, ensuring transparent communication and timely delivery of requested documentation, resulting in successful audit outcomes.
  • Developed and presented comprehensive training materials on quality systems, resulting in a 30% increase in employee understanding of quality controls.
  • Reviewed and validated investigation reports, ensuring the robustness of root cause analysis and effectiveness of corrective actions, leading to improved audit readiness.
  • Analyzed supplier performance data and implemented risk management strategies that improved supplier quality performance by 53%, reducing defects across ServiceNow.
  • Utilized Failure Mode and Effects Analysis (FMEA) to identify potential points of failure in products, increasing overall quality by reducing failure rates by 73% %.
  • Conducted thorough investigations into product quality issues, creating corrective action plans that resulted in reducing recurring issues by 41% within 17 months.

Affiliations

  • Led initiatives under the BioPhorum Operations Group (BPOG), focusing on quality-driven outcomes in biopharmaceutical manufacturing.
  • Certified Quality Engineer (CQE) through the American Society for Quality (ASQ), specializing in data-driven quality process analysis.
  • Engaged with the Quality Management Working Group at Lakeside Partners, advancing continuous process optimization in production environments.
  • Contributor to the Pharmaceutical Quality Group (PQG) forums, participating in discussions about pharmaceutical quality assurance and compliance.
  • Contributor to regulatory audit readiness teams, implementing quality management systems that led to successful Scrum Master by Summit Group in 2018.
  • Certified by the Institute for Validation Technology (IVT), specializing in quality validation for regulated environments.
  • Leader of Good Laboratory Practices (GLP) Task Force at system, facilitating compliance and reducing audit findings by 31%.
  • Certified by the International Organization for Standardization (ISO), specializing in ISO framework regulations and compliance.
  • Affiliated with the Regulatory Affairs Professionals Society (RAPS), contributing to ongoing industry discussions on compliance and regulatory trends.
  • Achieved Quality Auditor Certification from the National Contract Management Association (NCMA), ensuring high adherence to contract compliance.

Certifications

  • Salesforce
  • Certified GMP Professional 2020 - Harbor & Co.
  • Design Control for Medical Devices Certification 2020 - Northwind
  • Certified Quality Engineer (CQE) – 2023, ASQ
  • First Aid/CPR
  • Certified Calibration Technician (CCT) - 2021, ASQ
  • ISO 13485 Lead Auditor Certification 2017 - Ironclad Systems
  • Post-Market Surveillance for Medical Devices Certification 2022 - Beacon Labs
  • Statistical Process Control (SPC) Training Certification 2022 - Northwind
  • ISO/IEC 17025:2017 Internal Auditor Certification 2016 - Beacon Labs

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