Data Systems Power User - QA

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 35,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Data Systems Power User serves as a power user and data steward for IT systems supported by Quality Assurance, including Darwin, PMX, SAP, TrackWise, Veeva, RCM/RIM and Certificate of Analysis management. The Power User is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. This role is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews, creation and revision of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.

• Power User for IT Systems supported by QA (Darwin, PMX, SAP, TrackWise, Veeva, RCM/RIM)
• Creates/revises documents, such as specifications and procedures
• Collaborates with cross-functional partners, such as Operations, TS/MS, Engineering, Logistics, and QC Labs to streamline processes and update computer systems
• Investigate non-conformances
• Approves GMP documents

Basic Requirements:

• Bachelors Degree (computer systems, science, engineering related degree preferred) or relevant pharma industry experience
• Experience as a power user or data steward in computer systems, preference to LIMS systems and SAP

Additional Preferences:

• Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods
• Understanding of pharmaceutical materials management, laboratory specifical management as well as basic understanding of how it relates to registrations and commitments
• Experience managing and prioritizing multiple project timelines
• Experience configuring data management systems beyond end-user access

Additional Information:

• Overtime may be required.
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Minimal travel required.
• Position is located at the Lilly Technology Center - South.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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