Scientist – Quality Control Laboratory Informatics

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

• Performs and/or supports the laboratory with the validation of laboratory equipment and software systems.
• Supports the establishment and maintenance of the validated state of software-based computerized systems in use within the laboratory.
• Leads and/or supports site deployment and upgrades of QC laboratory IT systems such as Lab Vantage LIMS, Empower, MODA, NuGenesis ELN and SDMS.
• Ensures data integrity by design within the QC laboratory.
• Acts as QC laboratory data integrity local representative.
• Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.
• Acts as a contact SME for QC laboratory IT systems.
• Performs non-terminal record monitoring activities.
• Supports audit trail discrepancies if found during system audit trail review.
• Supports continuous improvement of quality systems as they relate to the QC laboratory.
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
• Supports audit and inspection activities for the laboratory.
• Implements and complies with corporate, site, and laboratory safety standards.

• Bachelor’s degree in a computer science, life science, or applied science field.
• IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
• Minimum 3 years experience in a GMP laboratory.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

• Master’s degree
• Proficiency with computer systems including Microsoft Office products, Lab Vantage LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Experience operating or implementing laboratory IT systems including LIMS and Automated Lab Execution systems.
• Experience with master data management activities including specifications, test methods, sample plans, and product configurations within Lab Vantage
• Experience with performing data migrations and master data transfers across environments (DEV/TEST or STAGE/PROD)
• Investigation and deviation management experience.
• Demonstrated proficiency in computer system validation.
• Experience with compliance requirements and regulatory expectations.
• Excellent oral and written communication skills and demonstrated through documentation and presentation skills.
• Demonstrated accuracy and proficiency in analytical skills.
• Ability to work in a laboratory environment including wearing appropriate PPE and other safety related equipment or considerations.
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