QA Document Control Coordinator
Effectively managed and maintained all aspects of the document lifecycle processes. Facilitated change development and trained personnel throughout company. Contributed to the success of the company by collaborating inter-departmentally on various project launches.
- Organized document backlog resulting in performance improvement and reduced document review/approval turnaround time from over 30 days to 14 days or less
- Designed and implemented forms and templates to streamline Quality Management System (QMS) processes in order to ensure consistent, compliant documentation.
- Key contributor on a team that implemented a new electronic document management system and training program that resulted in improved company compliance.
- Performed Quality review of documents, processed document change notices to completion (approval/release) for variety of document types including: SOPs, Forms, Clinical Protocols, Report, Work Instruction, Technical, Engineering Drawings, Marketing Materials (social media, advertising and promotional), Training exams, etc.
- Contributed in Quality Assurance activities including quality metrics monitoring, internal auditing, database management, and external audits preparation.
- Key contributor in establishing system processes and software validation testing for new or improved Quality Systems.
- Document archival and retrieval from off-site storage facility.
- Supported Regulatory Affairs / Human Resources and maintained personnel files and training records.