Lisa Ehrhardt Email & Phone Number

Roundlake, Il

Aid in the creation of user acceptance testing. Create and publish artwork. Execute layouts and illustrations in accordance with internal specifications and printing requirements. Aid in the creation and writing of training materials. Train internal and external personnel on documentation and labeling related processes and systems. Review documentation for accuracy and compliance to procedures. Chair change control meetings. Maintain, proofread and change procedures as necessary.

• Change Control Owner for various labeling changes, maintained in Trackwise 8. Currently coordinating project of 40 label changes, as well as Bills of Material and PCS changes.• Project Management skills; work with 20+ Product Owners to pinpoint each label change and where it is in the process of Agency approvals and reviews and incorporate changes. • Work with Product Owners to mark up drug product labels, complete required forms and act as liaison between RA and Labeling.• Experience in manual and electronic proofreading.• Trained in BaxEdge to mark up documents in RAs Secure Online Document Management System (BaxEdge)• Trained using ISI writer to convert, update, and submit Annual Reports.• Trained in BaxEdge to submit Annual Reports to Publishing and Reg Opps Groups.

•Utilizes the Trackwise System (GSQTS) for maintaining Supplier Quality Records, reevaluations and audits. Create, update and advance records as needed.•Determine and create/obtain re-evaluation requirements based on type of service/supplier (Drug, Service or Software) such as Quality Agreements, Credentials, Audit Plans and Audit Reports and Closures.•Heavy communication with Suppliers and locations of use to obtain requirements.•Perform Baxter regulatory reviews, and obtain vendor quality certifications.•Work with Locations of Use to correct various master, part, and LOU updates.•Search BPLM for missing Material Specifications, update part records accordingly.•Work very closely with commodity code managers/auditors to ensure requirements are in place•Decommission suppliers as needed•Initiate and track SNC and NSRs•Access and search JDE, BAS, Ariba and contact various finance employees tools to identify•spending to determine if a supplier is being used and locate the Baxter user•Archive departmental studies and protocols.

•Coordinate delivery of Certificates of Free Sale and other required regulatory paperwork to country Affiliates in order to register new and modified nutritional products•Compare and update combined US and International standards and perform assessments for Master Labels and technical documents•Proofread Label changes from drafts, bill of materials, finished product specifications, master product specification and other technical documents•Enter and Update Product Launch Database Entries uploading proper country required documents•Update monthly metrics for upper management•Create and update global product launch timelines

*Facilitate the training and implementation of the Corporate Certificate of Compliance program. This also includes but is not limited to interacting with CoC contacts around the globe to ensure timely processing of certificates in each area of the company, configuring periodic status reports for Quality Leadership Team members, create and maintain certificate tracking database and managing hard copy files for audits.*Assist in the Periodic Review process for all documents managed by DDM (Medication Delivery, Renal, Corporate Quality, Global IT, and Technology Resources)*Training File Administrator (TFA) Update training records in ISOtrain and maintain accurate training files for 45+ employees *Report open training requirements to management monthly*Resolve training file discrepancies*Co-Chaired team to revamp departmental website and provided all technical support, coached new Baxter web authors on TeamSite.

Sr. Department Specialist Responsible for the modification and release of Standard Operating Procedures, Technical Summaries and Procedure Specifications into Metaphase. Provide administrative support for Director, Data Documentation Management and group of 46 employees. Training file administrator/auditor.*Developed and maintained Access Database to chart departmental activities and manage workflow.*Coordinated the integration of three divisional groups into one after the Quality reorganization.*Created and maintain departmental web page*Created and updated several online learning courses.

Responsible for ordering articles, patents and standards for multiple internal customers worldwide.* Worked with Document Delivery vendor to develop a customized web-based ordering system that allowed customers and staff members to quickly and easily place and track article orders. Participated in testing system to allow electronic delivery of journal articles and standards.* Designed and updated content for a copyright website that provide information and procedures for compliance with copyright laws.

Responsible for department charge-back database; administering contracted internet based information services; supporting department computer hardware/software needs; interfacing with IT support team; and designing/publishing/maintaining 10 internet websites.* Developed and maintained Access database that tracked all department activity and charged-back $500,00+ indirect and direct charges.* Created and maintained Access database with web interface for employee passwords; it allows single password and point of access to multiple internet-based services.* Saved department $10,000/year in maintenance and hosting fees.* Build database with web interface that allowed corporate customers to share costly market reports.

Education record

Awarded a general education diploma.

Various Courses, Various General And Computer Information Science

Baxter Continuing Education Basic, Intermediate and Advanced Excel, Word, Access, Fireworks, Tango, Dreamweaver UltraDev; courses - 40.