Responsible for post-execution batch record review. Write, review, edit and approve master documentation. Approve studies and qualifications of equipment. Review documentation related to GMP activities. Ensure data integrity requirements are complied with. Perform internal audits. Participate in supplier qualification program. Approve: Change Management Documentation, Service Orders, New Equipment, Equipment Discrepancy Reports, Protocols.

Participated on improvement teams to provide training on documentation and tools. Subject Matter Expert for the Change Control Management and Teamcenter Unified systems. Administered training, access, guidance, and failure resolution to achieve desired results. Created and distributed metrics, reports, and prepared necessary materials to support and drive Hoshin goals. Prepared site and regional communications resulting in Best Practices, procedural updates, and system enhancements. Routinely complete gap assessments to ensure compliance. Participate in internal audits, external audit preparation and completion of commitments. Active Nonconformance and Preventive Action Owner.Professional Highlights:▪ Spearheaded the update to the document approval structure from multiple procedures and reduced the number of approvals required by 15.92% to support and streamline the Quality Management System.▪ Identified and implemented opportunities as an Expertise Council Member for improvement to global governing procedures and system requirements for Change Control Management.▪ Integrated Teamcenter Unified for three (3) acquired facilities as a Community of Practice Team Member as well as United States and Canadian Lead Regional Coach to 30 personnel by facilitating training and aligning system functionality to site requirements.▪ Scripted and executed Performance Qualification testing in Hewlett-Packard Application Lifecycle Management for Teamcenter Unified upgrade.▪ Created local DocuSign training materials and provided end user training to drive a reduction in paper usage, efficiency, and timeliness to obtain record approvals.

Integration team member for TrackWise8, ISOtrain, Baxter’s Product Lifecycle Management and Teamcenter Unified – identified as Subject Matter Expert for each. Provided training, access, guidance and failure resolution through Account Request Management, Full Permission usage, Lead System Design Administration, Group Administrator and Coaching. Instrumental in product labeling change control as well as Device Master Record updates and Periodic Review timelines.Professional Highlights:▪ Refined local procedures to harmonize with corporate policies resulting from our site acquisition.▪ Qualified trainers as a Baxter Master Instructor.

Responsible for ensuring that administrative activities associated with the document change control process are conducted in accordance with the company’s Quality Management System policies and procedures, including activities associated with administering the document control process, and maintaining documents, indexes, logs and records.

Provided administrative and executive support within fast-paced 50-person company with residential and commercial construction portfolio. Personal assistant to the President / Owner for business and personal correspondence. Office Manager responsible for accounting files along with bank reconciliation and data entry for budgets, office supplies, meeting and special events preparation. Run errands to include filing county paperwork, transferred possession of blueprints to the appropriate architect, sub-contractor, or client; giving or receiving supplies for public events. Prepare documentation for monthly payment requisition.Achievements:- Identified the need for a singular, all-inclusive MSDS catalogue by collecting current material and knowledge from staff and material inventory.