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.

• 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.

• 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.

• 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.

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.

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.

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.

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.