LabVantage Master Data Steward

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The LabVantage Master Data Steward is part of a team of informatics professionals who work closely with IT to identify, develop, validate, deploy, maintain, and defend globally owned, GMP compliant, informatics applications throughout their lifecycle. Represent the needs and interests of the business areas they support and act as their voice and advocate.

Key Responsibilities:

• Master Data Creation: Build or coordinate with a third party the creation of master data in LabVantage, including Products, Specifications, Sampling Plans, Analytes, and Tests to support Batch Release, Stability Management, cleaning, and process validations for manufactured materials.
• LES: Lead the design and creation of lab execution worksheets in the Lab Execution System.
• Data Discovery Assistance: Assist sites during data discovery to identify the scope and the master data elements that need to be created as part of the LabVantage deployment.
• Data Stewardship: Coordinate creation, migration, and review of master data required to implement LabVantage. This includes both LIMS and LES master data.
• Verification and Testing: Participate in the verification and testing of master data and facilitate the simulation of method execution.
• Change Management: Evaluate site master data change requests, feasibility and global impact. Prioritize requests according site needs.
• Key Process Indicators: Identify and report key process indicators to report the progress of the master data creation.
• Third-Party Management: Manage the relationship with the third party assisting in the creation of LabVantage master data.
• Compliance: Ensure that the design of LES test methods is compliant with data integrity and GMP requirements.
• Global Process Standardization: Understand local requirements and apply them to standardized global business processes. Communicate new and changed business processes to sites and influence the sites to adopt these globally standardized processes and global tools to support the site’s intended use of LabVantage.
• Instrumentation Team Collaboration: Work with the instrumentation team to ensure that the master data in LabVantage enables the electronic acquisition of instrument data.

• Support Team Participation and Issue Resolution: Provide ongoing support and issue resolution related with master data. Coach and mentor system users, share key learning and best practices with the global LabVantage community to increase their system knowledge, and identify transferable work processes between sites.
• Inspection Support: The LabVantage Data Steward is part of the team that will provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows.
• System Release Support: Support system releases by executing UAT and updating impacted procedures.

Education

• Minimum of Bachelor’s Degree or equivalent experience in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field.
• 5+ years of laboratory experience
• Experience working in/with GMP laboratories

Skills

• Strong scientific background
• Clear understanding of quality laboratory issues and activities
• Experience in defining and improving business processes
• Knowledge of cGMP and quality systems
• Strong understanding of GMP requirements and data integrity principles.
• Proven work with computer systems and their adaptability to existing business processes. Extensive knowledge of analytical meth