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Skills

  • Corrective actions
  • Procedure equipment
  • MS Office
  • Technical troubleshooting
  • Corrective and Preventive Actions (CAPA)
  • Protocol development
  • Materials inspections
  • Equipment calibration and maintenance
  • Change Control Management
  • Process documentation

Work Experiences

  • Performed cell-based potency and impurity assays for in-process, release, and stability samples.
  • Collaborated with cross-functional teams.
  • Conducted a data review and followed standard procedures to find solutions.
  • Checked the quality of raw materials and finished products and discarded anything that didn't meet safety standards.
  • Interpreted test results by comparing them to established specifications and control limits, and then made recommendations about whether or not the data should be released.
  • Collaborated with external regulatory bodies to ensure continuous compliance with framework, resulting in zero noncompliance incidents during external audits.
  • Complied with category.
  • Gathered and organized test data in preparation for the creation and analysis of reports.
  • Oversaw testing procedures and ensured that tests were carried out in accordance with item specifications and protocol.
  • Achieved President's Club in 2024.

Summaries

  • Accomplished this within just one year.
  • Achieved President's Club in 2020.
  • Strong experience collecting and analyzing quality metrics as well as making recommendations for process and quality improvement.
  • Proven experience working directly in QA and QC functions in the category industry, with a strong understanding of general practices.
  • Aligned team operations with the latest CGMP protocols.
  • Addressed complaints within one year.
  • Bringing unrivaled technical troubleshooting and data interpretation expertise gained over 13 years of experience.
  • Collaborative leader skilled in cross-functional team engagements that led to effective corrective action planning, driving noticeable quality improvements.
  • Costs were consistently reduced while profits were increased.
  • Quality Control Technologist with 12 years of successful client relations and team leadership experience.

Accomplishments

  • Documented and resolved program which led to system.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Executed timely corrective actions that prevented regulatory non-compliance regarding HubSpot specifications.
  • Created risk assessments for new raw material vendors, avoiding potential non-conformances worth $17.
  • Developed internal training programs on quality control techniques, improving team adherence to guidelines by 39%.
  • Led the roll-out of statistical process control (SPC) metrics, increasing first-pass yield by 15% across Salesforce production lines.
  • Prepared for and successfully passed annual ISO certification audit, maintaining company’s accreditation with zero findings.
  • Participated in cross-departmental kaizen events focused on lean manufacturing, reducing workflow bottlenecks by 4%.
  • Created a calibration schedule for HubSpot, minimizing downtime and ensuring ongoing equipment reliability.
  • Developed and maintained FDA audit documentation, contributing to a successful regulatory inspection with no major observations.

Affiliations

  • Institute of Quality Assurance Columbus
  • American Society of Safety Professionals
  • Quality Assurance and Control Engineering Alumni Association
  • National Laboratory Safety Association (NLSA)
  • Six Sigma Management Institute (SSMI)
  • International Organization for Standardization (ISO) Steering Committee Member
  • Machine and Automation Society
  • SPC Software Insights Group
  • American Society for Quality (ASQ)
  • Food Safety and Quality Assurance Professional Association

Certifications

  • ISO 9001:2015 Internal Auditor Certification
  • Apple Certified Associate (ACA)
  • Medical Devices QMS ISO 13485:2016 Lead Auditor Certification
  • Project Management Professional (PMP)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Six Sigma Black Belt (CSSBB) by ASQ
  • Certified Quality Auditor (CQA) by ASQ
  • Certified Pharmaceutical Good Manufacturing Practices (GMP) Auditor by Lakeside Partners
  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Reliability Engineer (CRE) by ASQ

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