Bothell, Washington, United States
As part of the Quality Systems group, assisting with the integration and implementation of the BMS chosen platform (Veeva) from the legacy software solution (etq). Working as a site champion for Change Control, Deviations and CAPA Creating site project plan for Deviations and CAPA Facilitating site champion meetings Assist in liaising between the Global and JuMP site groups.
Sr. Manager Quality Information Systems • Provided day to day management of staff, including setting of assignments, tracking of deliverables, establishing quality goals in alignment with corporate goals, and setting staff development objectives • Acted as business process owner of GMP Quality electronic systems including but not limited to electronic Document Management System and electronic Records Archive System • Established relationships with key personnel in GMP functions to ensure collaboration, foster cooperation, and ensure positive outcomes. • Contributed to the creation and revision of cross-functional policies and procedures ensuring compliance with applicable regulatory requirements, guidance, and industry best practices • Worked with leaders and staff of GMP functional areas to ensure new or revised policies and procedures were alignment with company policies and document control hierarchy requirements. • Reviewed and approved Change Controls, Deviations, and CAPA related to area of responsibility. • Sought out and applied continuous improvements to functional area of responsibility and supported functional areas. • Initiated new Document Hierarchy Manager QA Document Control • Managed controlled documents via Electronic Data Management System (EDMS) • Issued controlled Forms, Logbooks and controlled SOP locations • Managed and maintained stored files of Lot release binders, Validation Documents, QC Assays • Managed and maintained separate GLP archive area • Managed and maintained off site storage for both GMP and GLP via vendors and Test sites Quality • Implemented and validated 2 DMS systems (MasterControl and Compliance SharePoint – (Qumas – BIOVIA)) • Implemented and validated QMS software solution from ETQ. • System Administrator of Quality Software Solutions (QMS, DMS LMS) • Initiated Digital Documentation Initiative
Document Control Associate • Updated Agile DB from 2005 to 2006 SP2 MP2 • Oversaw the work flow of all company documentation (i.e. Release notes, Schematics, CAD Drawings) • Assisted engineers in writing and formatting of their documentation • Established QA Document Control Systems • Trained users on Document Control System SOPs • Maintained database of documents in Agile
Document Control Supervisor • Managed three Documentation Specialists • Oversaw the issuance of all company documentation (i.e. Lot Numbers, Controlled Forms, Methods, Protocols, Batch Records) • Ensured QA Document Control Systems are adhered to • Responsible for training on Document Control System SOPs • Ensured preparedness for both internal and FDA audits • Improved the Document Control infrastructure by implementing Change Control and Document Review Tracking • Created and maintained Document Control Database • Supported Document needs for satellite sites (Montreal and Baltimore) • Updated Controlled Notebooks • Assisted scientist in writing their documents (Methods, Master Batch Records, SOPs, and Specifications.) • Wrote and revised Document Control System SOPs