Lilly Consultant Chemist DI – QC – IAPI (QC eSystems) 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 Consultant Chemist Data Integrity (DI) – QC – IAPI (QC eSystems) provides electronic system technical and compliance support for Indianapolis API Operations QC. The Consultant Chemist DI – QC – IAPI will be well versed in internal and external compliance commitments and will be responsible for evaluation of electronic systems, processes, and data generated by API QC. This includes routine assessment of business processes, electronic and paper systems, data maintenance and flow as well as setting local procedural guidance to ensure quality by design in analytical testing. The Consultant Chemist DI – QC – IAPI may provide consulting support outside of API QC and will work closely with individuals in QA and similar data integrity roles across the API manufacturing organization. The Consultant Chemist DI – QC – IAPI will participate in agency and internal inspections, change management, observation/deviation management, reviews, and related initiatives. The Consultant Chemist DI – QC – IAPI will provide additional capacity for eSystems analysts in support of emerging technologies, compliance initiatives as well as routine support for electronic systems (ie., standalone systems, SmartLab/NuGenesis (ELN), LIMS, spreadsheet use, and legacy processes).
SME for laboratory computer system audit activities and validation
SME for data integrity requirements internal and external to the organization
Works collaboratively with a diverse personnel base to improve DI across API manufacturing
Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements
Sets direction of data integrity and assesses 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
Understands laboratory infrastructure and acts as a liaison between QC and the IT organization to reduce DI risk
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 QC eSystems 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
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, NuGenesis, Darwin, Empower and other E3B laboratory systems)
- 4+ Years of QC experience with a focus on electronic lab notebooks and instrument infrastructure.
- Bachelor’s Degree (or equivalent experience)
Must complete learning plan for a Consultant Chemist DI – QC – IAPI (QC eSystems)
Works closely with laboratory teams, manufacturing and process analytics
Required to provide on-call support coverage
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!