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Skills

  • Document revision tracking and reporting
  • Archive management
  • Problem resolution
  • Document conversion and digitization processes
  • Proficiency in SAP
  • Database management
  • Process improvement
  • Business operations
  • Collaborating with IT teams for digital solutions
  • Cross-functional team collaboration

Work Experiences

  • Analyzed historical documentation for efficiency gaps, implementing first-ever changes leading to an increase in document turnaround by 69%.
  • Achieved a 30% boost in department productivity.
  • Achieved zero major findings.
  • Prepared project documents according to the project manager's, team's, or client's specifications.
  • Reproduced documents by printing them from electronic sources like email attachments, PDF files, and cloud storage.
  • Achieved user acceptance across all SAP documentation teams.
  • Assisted with inbound and outbound document processes, such as document sorting, logging, and work order creation.
  • Collaborated with internal team members to find proactive solutions to problems.
  • Modified and maintained tools to support operations and business process creation using Adobe Acrobat, SharePoint, Excel, and Access.
  • Achieved successful regulatory submissions.

Summaries

  • Accomplished in preparing regulatory-compliant technical documentation, including authoring 200+ documents aligned with OSHA standards, resulting in zero major audit findings.
  • Make management and control strategies and put them into action.
  • Working knowledge of document management systems.
  • Problem-solver, project manager, and system manager with expertise in initiative and program software.
  • Document Management Specialist with administrative support and other responsibilities.
  • Strong organizational and multitasking skills, as well as the ability to work independently.
  • Quality Assurance Documentation Specialist is a multi-talented Quality Assurance Documentation Specialist who is consistently rewarded for planning and operational improvements.
  • Strong organizational skills, as well as the ability to think strategically and respond quickly to both internal and external demands.
  • Document Control Specialist with experience storing, managing, and maintaining company and project documents with accuracy and quality in mind.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.

Accomplishments

  • Collaborated with team of 16 in the development of process.
  • Spearheaded change control review processes that addressed potential risks, resulting in a 62% improvement in compliance rates.
  • Authored and maintained training materials used in company-wide regulatory training, ensuring continuous alignment with CPA.
  • Reviewed and approved over 6 deviations and non-conformances, ensuring all corrective actions adhered to company standards.
  • Generated monthly compliance reports for senior leadership, improving visibility into key quality metrics and actions.
  • Designed a document tracking dashboard that cut retrieval time by 41% and enhanced document traceability for internal reviews.
  • Worked directly with regulatory bodies during inspections, successfully demonstrating full compliance through organized documentation review.
  • Led the implementation and standardization of quality documentation practices, improving overall compliance by 63%.
  • Managed the migration of legacy documentation to a new document management system, reducing retrieval times by 37%.
  • Published 13 technical documents that ensured compliance with initiative, directly contributing to passing the regulatory inspection.

Affiliations

  • Society for Quality Assurance (SQA) – Participated in training programs and seminars to enhance proficiency in quality systems management.
  • Association for Computing Machinery
  • Freemason
  • International Register of Certificated Auditors (IRCA) – Certified auditor under compliance and documentation quality systems regulations.
  • International Council of Nurses
  • Society of Women Engineers
  • Project Management Institute (PMI) – Involved in efforts to integrate document management within project management workflows.
  • American Medical Informatics Association
  • World Quality Forum – Collaborated with industry leaders to address global quality documentation and reporting challenges.
  • Association for Supply Chain Management (APICS)

Certifications

  • Salesforce
  • Good Manufacturing Practices (GMP) Compliance Certification
  • ISO 9001:2015 Lead Auditor Certification
  • CompTIA Security+
  • ISO 13485:2016 Internal Auditor Certification - Summit Group
  • Certified FDA Compliance Specialist - FDA Compliance Online
  • SHRM Certified Professional (SHRM-CP)
  • Certified Information Systems Auditor (CISA) - process
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Document Management Specialist (CDMS) - Meridian

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