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Skills

  • Document lifecycle management
  • CAPA (Corrective and Preventive Action) coordination
  • Supervision
  • Detail-oriented documentation practices
  • Mail merging
  • Invoicing support
  • Customer service
  • Document revision tracking and reporting
  • Data logging
  • Archive management

Work Experiences

  • Bills of materials, ECOs, ECRs, and ISO documents were all created, routed, and data input by me.
  • Maintaining an orderly and clean control room aided in efficient document processing.
  • Achieved zero observations during audits.
  • Devised and implemented a new process for approving design plans and engineering change requests in order to reduce cycle time.
  • Worked with clients to review contracts, respond to questions, and determine special circumstances.
  • Data books in physical, digital, and CD formats were created by me.
  • Provided contract development teams with training on proper responses and contract flexibility.
  • Led the development, development, and maintenance of multiple complex and high-priority contracts between the company and its business partners, vendors, and suppliers.
  • Tracked the performance of system and process integrity, vendors, internal workflows, and SLAs by monitoring and creating control reporting.
  • Collaborated with internal staff to process documents and send them to the closing department.

Summaries

  • Excellent attention to detail and a strong sense of organization.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Electronic filing systems, various document management technologies, and scanning experience are all familiar and experienced.
  • Dedicated to learning, growing, and succeeding in Customer Service.
  • Growth mindset and eagerness to assist the team in moving the company forward with any task.
  • Document Review Specialist with a track record of successfully negotiating, researching, and communicating.
  • Working knowledge of document management systems.
  • Compliance requirements, security standards, and access management are all areas in which he excels.
  • Within Customer Service, senior Quality Assurance Documentation Specialist and outstanding performer in budget management and project management.
  • Provided vision, direction, development, and maintenance of multiple complex and high-priority contracts that directly impacted the organization's business strategies.

Accomplishments

  • Supported the rollout of a new QMS that enhanced documentation accuracy and compliance for 18 quality-critical processes.
  • Partnered with IT and Operations teams to automate document approval workflows, decreasing approval turnaround time by 72%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Developed a comprehensive documentation retention and archiving policy that ensured 100% audit readiness for 2023.
  • Administered controlled access to documentation files, ensuring data integrity for over 6 critical quality documents.
  • Created and maintained document templates to streamline document authoring, which reduced approval cycles by 15 days.
  • Managed change control documentation for Microsoft Excel modifications, accelerating approval by 51%.
  • Published 13 technical documents that ensured compliance with initiative, directly contributing to passing the regulatory inspection.
  • Collaborated with team of 16 in the development of process.
  • Worked directly with regulatory bodies during inspections, successfully demonstrating full compliance through organized documentation review.

Affiliations

  • Medical Devices Documentation Society (MDDS) – Involved in compliance and submissions regarding medical device documentation processes.
  • National Association of Social Workers
  • Global Compliance Panel – Participated in webinars focusing on risk-based thinking and root cause analysis in documentation practices.
  • American Medical Informatics Association
  • Parenteral Drug Association (PDA) – Contributed to forums on Good Documentation Practices (GDP) and compliance issues.
  • International Register of Certificated Auditors (IRCA) – Certified auditor under compliance and documentation quality systems regulations.
  • International Conference on Harmonisation of Technical Requirements (ICH) – Participated in discussions about global standards for quality documentation in the healthcare sector.
  • Freemason
  • Association for Supply Chain Management (APICS)
  • Institute of Validation Technology (IVT) – Collaborated with industry experts on validation protocols for document management systems.

Certifications

  • CompTIA Network+
  • Document Control Certification - Institute of Quality Management (IQM)
  • Certified Professional in Healthcare Quality (CPHQ) - National Association for Healthcare Quality (NAHQ)
  • CompTIA A+ Technician
  • Google Certified Professional Cloud Architect
  • Certified Quality Improvement Associate (CQIA) - ASQ
  • Certified Biomedical Auditor (CBA) - ASQ
  • Cisco Certified Network Associate (CCNA)
  • Certified Professional in Electronic Records Management (CERM) - ARMA International
  • Advanced Change Control Management Certification - Harbor & Co.

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