Wendi Ledwitz Email & Phone Number

• Manage Master and Static Data in SMLIMS.• Create and update Analyses, MLP Specifications, Sample Plans, Templates, COAs and EM LIMS builds and associated Jobs and Samples. • Manage LIMS builds for Technical Transfers.• Update LIMS builds for Retroactive Protocol Testing.• Review and approve static data builds.• Develop and maintain Tracking Report to monitor Change Actions in Veeva.• Update and review SOPs, reference and technical documents for approval in DCA document management system.• Serve as Point of Contact on rotating basis to resolve urgent and ad hoc requests for Quality Assurance, Quality Control, Manufacturing and the lab.• Analyze and update meta data for pilot Microbial Trending Tool.• Create tables and develop charts for KPI Metrics.• Implement LES Procedure updates in SMLIMS.• Utilize Update tool to update Stability Products and Articles. • Monitor PPI Dashboard to troubleshoot and resolve potential issues due to outages.• Process requests to access SMLIMS in BMS Service Now system.

New Brunswick, New Jersey, United States

Manage Master Data in the Global Product Data View System (GPDV) and SAP. Create and update Enterprise and SAP Material Codes and attributes. Manage updates to Purchase Orders in SAP, including creating return lines, additional quantity lines and closing POs. Manage the discontinuation of materials in SAP including, but not limited to inactivating materials in the ZVSDTOLLDOH Table, confirming Source List value and flagging materials and purchase information records for deletion. Resolve issues in SAP related to the manual creation of Goods Receipts through the development and coordination of cross-functional teams and the identification and successful implementation of a multi-level solution. Assist in the creation and updating of the GPDV Data Catalog that houses Data Standards and Material Definitions and Rules. Develop and implement training procedures. Data remediation of materials and their attributes in GPDV and SAP. Update transfer pricing in SAP for divestiture. Perform UAT Testing. Analysis of usage of data standard values in GPDV system. Perform Serialization research and Product Pack Verification in ATTP.

Edison, Nj

• Managed Contracts and Pricing for the Central Region• Created agreements and notification letters with respect to pricing execution for Interventional Cardiology and Vascular Products • Prepared responses to Requests for Proposals• Utilized SAP and pricing tools to analyze data for the preparation of contracts and resolution of pricing exceptions

Trenton, New Jersey

Responsible for developing acknowledgment process procedures, implementing data integrity projects, creating macro to improve efficiency of data updates and preparing daily and weekly stewardship reports.

Bridgewater, New Jersey, United States

Manage change orders in the Ethicon PLM system including the formation of new finished good codes, creation and modification of bills of materials, modification of manufacturing routes, definition of item attributes and management of product lifecycle.Work closely with senior project team members to support CAPA's, Product Launches, Production Changes and originate Change Orders in the Ethicon change control system.Ensure alignment of the project deliverables to the business goals throughout the project delivery lifecycle to ensure project solutions closely align with the overall enterprise model and IT capabilities.Track time, status and other project updates in the Department's PPM tools necessary to maintain clear visibility for project to be on time and on budget delivery.Utilized vlookups, pivot tables and formulas in MS Excel for the purposes of data validation and data cleansing. Performed data analytics to further data integrity goals.Helped cross functional team from multiple sites to revise more than 1,200 parts by modifying attributes for 8,000 components and 3,600 substitute components in order to align with new requirements for company's cost roll-up procedure. Helped identify Bills of Materials that utilized alternate BOM components and assured the accuracy of the modifications. These changes supported over $305,946,728 in sales for 2015.

Red Bank, New Jersey

Responsible for management of contact data to prepare for implementation of Contactease database system. Review, research and edit contact data to improve data integrity. Serve as lead on weekly conference calls. Import contact data from multiple sources into Contactease database. Various administrative duties.

Juris Doctorate, Law

Activities and Societies: The Women and Law Clinic, Moot CourtMonmouth County Bar Association Scholarship (3 years), The Thomas D. Nary.

Bachelor Of Arts, Political Science Major; American Literature Minor

Activities and Societies: Alpha Chi OmegaGraduated Cum Laude