Lilly Chemist – QC – IAPI (eSystems Automation) in Indianapolis, Indiana
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.
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.
Position Brand Description:
The Chemist – QC – IAPI (eSystems Automation) provides electronic automation system technical and compliance support for Indianapolis API Operations QC. The Chemist – QC – IAPI is responsible for design and maintenance of automation systems, execution of laboratory CSV initiatives, analytical method management, eLN templates/scripting, and QC infrastructure requests. This individual will provide support for related QC activities (i.e.: support, new equipment installation, data integrity, agency and internal inspections, system upgrades, change management, observation/deviation management, reviews, and related global initiatives).
Provide oversight, development, ongoing support and maintenance of QC automation equipment (ie: Hamilton, Tecan, and Eppendorf liquid handlers and associated robotic hardware)
Provide support for the implementation and maintenance of electronic notebooks
SME for laboratory computer system audit activities, validation and periodic reviews
Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements
Understands direction of technology and its impact on laboratory business processes, quality systems and the QC organization
Implements programs/processes which improve overall compliance and quality in the QC Laboratories
Train and Mentor analysts through formal process/program
Assess, review and author change controls and deviations for eSystems and QC instrumentation
Utilize technical skills to lead or perform in-depth investigations affecting data integrity. Draws conclusions and performs root cause analysis investigations and recommends solution to prevent reoccurrence
Support laboratory infrastructure and act as a liaison between QC and the IT organization (e.g., instrument interfacing, data archiving, technology infrastructure and data parsing)
Evaluate new laboratory technologies for impact to other QC systems portfolio and provide direction in qualification of new equipment technologies
Improve laboratory quality systems; develop content, review and approve SOPs and training as necessary
Influences business areas’ understanding of their own business processes, identifies new opportunities, challenges the status quo, and helps develop recommendation for using ESystems Automation to improve business process productivity
Bachelor’s Degree (4 year College) in a scientific field related to the lab (e.g., Chemistry, Microbiology or Biology) or 4-7 years of relevant experience in a GMP laboratory
3+ Years of lab experience, QC preferred
Experience with a focus on electronic lab notebooks and instrument infrastructure.
Experience with laboratory automation equipment such as Hamilton, Tecan, or Eppendorf liquid handlers.
Proficiency with computer systems
Demonstrate strong oral, written communication and interpersonal interaction skills
Deep understanding of laboratory quality systems and their dependencies (e.g., TrackWise, SmartLab, Darwin, Empower and other E3B laboratory systems)
Additional Information :
Must complete Learning Plan for an Chemist – QC – IAPI (eSystems Automation)
May be required to provide off hours support coverage
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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).