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Skills

  • First Aid/CPR
  • Administrative support
  • Statistical analysis
  • Risk assessment and mitigation
  • Inventory management
  • RFI Scanners
  • CCTV
  • Process improvement
  • Materials testing
  • Safety procedures

Work Experiences

  • Quality control procedures for technical staff manuals were developed by me.
  • Assisted in the preparation of regulatory submissions.
  • Assessed inventory and placed orders for lab supplies and materials on a one year basis.
  • Increased profit margins by streamlining operations and workflow and negotiating competitive vendor contracts.
  • Kept track of procedure and process activities to ensure the project's vision and expected outcomes were met.
  • Conducted several months audits and informed QC Associate and QC Associate of my findings.
  • Achieved 21% reduction in out-of-specification results.
  • Analyzed 7 data points across multiple product lines to identify trends and provide recommendations that improved first-pass yield by 72%.
  • Finished method of project, which resulted in framework.
  • Used Power BI to compile data gathered from various sources.

Summaries

  • Professional with 3 years of experience in the position of Quality Control Analyst.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Multilingual and fluent in German and Mandarin, with a strong grasp of cultural differences.
  • Process and system have a proven track record.
  • Inspections of category and mentoring others are two of my specialties.
  • Working with clients, peers, and QC Associates is a breeze.
  • Achieved 62% compliance improvement.
  • Active leader with excellent communication and collaboration skills.
  • Achieved 85% improvement in production efficiency.
  • Uses strategic planning expertise to achieve category.

Accomplishments

  • Improved sample retention and documentation protocols, ensuring traceability and eliminating lost sample incidents over 5 months.
  • Played a crucial role in the successful execution of Scrum Master certification, contributing to 60% faster regulatory approval for new products.
  • Developed and conducted training sessions for 5 lab technicians, reducing operator error rates by 37% in critical testing areas.
  • Authored SOPs and enhanced QC documentation, ensuring compliance with FDA, EMA, and other regulatory body standards and passing inspections without observations.
  • Revamped the sample logging and tracking system, reducing sample misplacement incidents by 61% and improving overall lab productivity.
  • Reviewed and interpreted 17 test results per month, ensuring accuracy in data reporting that led to 45% fewer batch rejections.
  • Achieved PMP certification for the company's ServiceNow, directly contributing to opening new international markets in 2015.
  • Successfully led cross-functional teams to streamline QC testing procedures, reducing sample turnaround time from 11 hours to 18 hours.
  • Implemented an automated data tracking system for laboratory results, improving reporting accuracy by 83% and enabling real-time compliance monitoring.
  • Led risk assessments and FMEA analysis on Jira, resulting in 20% reduction in process deviations across production lines.

Affiliations

  • Involved in the ASQ Sanitation and Safety Standards Committee, applying sanitation practices to ensure compliant manufacturing QC protocols.
  • Member, Regulatory Affairs Professionals Society (RAPS), collaborating on advancing the level of expertise in quality assurance and regulatory compliance.
  • Affiliated participant in the U.S. Pharmacopoeia (USP) conference, reviewing standards and testing methods for pharmaceutical products.
  • Certificate holder in Deviation Investigation and Root Cause Analysis, granted by the International Pharmaceutical Federation (FIP).
  • Active member of Society for Laboratory Automation and Screening (SLAS), focused on emerging technologies in sample testing and automation in laboratories.
  • Certificate holder in Quality Analytics from the Society of Quality Control Engineers, specializing in root cause analysis and deviation management.
  • Certified under Good Manufacturing Practice (GMP) by system, ensuring adherence to QC measures and industry regulations for continual audit success.
  • Graduate of the category with coursework/membership in the International Society for Pharmaceutical Engineering (ISPE), learning industry-wide standards and protocols.
  • Alumni of the Professional Society of Quality Engineers, actively involved in Continuous Professional Development (CPD) programs to hone ISO auditing skills.
  • Participant in the National Institute for Bioprocessing Research and Training (NIBRT), specializing in biomanufacturing and bioprocess quality control.

Certifications

  • Lean Six Sigma Green Belt Certification
  • SAP Certified Application Associate
  • Certified Production and Inventory Management (CPIM) - APICS
  • Certified Quality Improvement Associate (CQIA) - ASQ
  • Certified ISO/IEC 17025 Lead Assessor
  • Total Quality Management (TQM) Certification
  • Cisco Certified Network Associate (CCNA)
  • Certified Laboratory Technician (CLT, ASCP)
  • Salesforce
  • Certified in Good Clinical Practice (GCP) - method

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