Matthew Spooner Email & Phone Number

Fox River Grove, Il, Us

Fox River Grove, Il, Us

Round Lake, Illinois, United States

Responsible for owning and managing all Advanced Surgery GBU labeling changes from initiation through implementation, inclusive of New Product Development, Geographic Expansion, Acquisitions, and Sustaining projects.Own all Advanced Surgery change controls through all Quality phases. Close all changes on time and within the recommended CCGB cycle time of 90 days.Lead multi-functional project teams through Global Labeling end to end process, with Regulatory, Quality, PDO, Marketing, Engineering, Supply Chain, and Manufacturing.Lead Project Manager for high visibility acquisition projects with all labeling activities (Claris Injectibles-2017, Mallinckrodt-2018, and Hillrom-2021).Supports Global Labeling Quality serving as a Labeling SME during audits and inspections, both internally and externally.Works with multiple manufacturing sites as Label/Packaging SME to research, test, and validate future/alternate vendors to reduce both cost and raw materials lead times.Leading core and extended team members across Baxter towards consistent and continuous improvement in key labeling initiatives such as UDI, EU MDR, global labeling compliance, and design control.Support the development and implementation of a global electronic labeling (eIFU) process, including interpretation, procedure development, website requirements,operational methods, and training within 6 months of project initiation.2023 BaxStar winner in Innovation - Revised Advanced Surgery top product Floseal to replace human thrombin with Recothrom, achieving faster production and significant cost savings.

Round Lake, Illinois, United States

One of seven team members selected to serve on the first Global Labeling Governance Team. Scope includes but not limited to training, process refinement, CAPA, NCR, education, business case development, and agile/scrum roll out.Drove measurable labeling improvements in labeling strategy, requirement and content tracking, electronic labeling (eIFU), UDI, and gap identification by developing and implementing templates, job aids and metrics collection.Led research with Smartsheet Team to build automated process demos and trainings for Global Labeling Team. Proposed business plan to Senior Management on the purchase and deployment of SmartSheet solution (Dec. 2021).Trained in both Corrective Action Preventative Action (CAPA) and Non-Conformance Report (NCR) documents and supported related actions across multiple incidents as needed.Created training/education presentations and led cross-functional forums for revised redlining process (both for label and technical specifications) and draft labeling processing.

Round Lake, Il

Managed all labeling changes for Clinical Nutrition portfolio from initiation through implementation. Obtained content requirements from Regulatory, Packaging, PDO, and Manufacturing.Owned labeling templates, die-lines, job aids, process flows, and cycle time metrics for all Clinical Nutrition product labeling.Led global cross-functional teams (internal and external customers) and created drafts for review, developed accurate redlines, reviewed change controls, and issued labeling into PLM system(s).Organized and led labeling status meetings with cross-functional teams, developed schedules, negotiated timelines, and drove project completion.Worked as technical liaison with print suppliers and manufacturing to resolve printing issues.PLM system SME with advanced knowledge of Author, Coordinator, and CS3 system roles.Supported Flexbumin transfer through TSA agreement, trained Takeda staff, created templates, and ensured all timelines for labeling were met.Led project with Packaging and Manufacturing to develop new Hot Stamp drawings that allowed Haina plant to switch suppliers, resulting in 50% lower costs and lead times.

Bellwood, Il

Oversaw state specific product submissions and all associated tasks, working directly with Gambling Control Board Regulatory personnel to secure timely product approvals.Researched, justified, and implemented procedural changes and SOP revisions for cost reduction and improved efficiency.Managed, coached, mentored and trained ~3 designers.Led weekly meetings with IT and Production departments, ensuring efficient product delivery, technology implementation, and improved efficiencies.Maintained company database, providing weekly updates to senior leadership on inventory gaps, sales metrics, and buying trends.Worked with Sales/Marketing to determine design project schedule, managed design execution, and ensured all Creative Department deadlines were met.Trained Creative Department personnel on hardware, software, and department SOPs.Created and maintained step-by-step SOP materials for staff use and training manuals for new hires.

Bellwood, Il

Executed technical design solutions while working within strict state regulatory guidelines and precise in-house manufacturing specifications.Worked with Packaging and Manufacturing to develop templates for die line purchase and press line implementation.Worked directly with Texas Lottery Commission in revising game image manufacturing specifications and standards to adhere to new state legal requirements.Created quality assurance measures and worked with Creative Director and HR Manager to implement as part of the company hiring process.Performed pre-press operations of RIPping, data proofing, large first-piece press approvals, and overall quality assurance reviews.

Lisle, Il

Chicago, Il

Bachelor Of Fine Arts (Bfa), Graphic Design And Illustration

Associate Of Arts And Sciences (Aas), General Studies