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Chemist - Quality Control IAPI (eSystems)

Indianapolis, Indiana

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Req ID R-15417 Title Chemist - Quality Control IAPI (eSystems) City Indianapolis State / Province Indiana Country United States

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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Position Brand Description:

The Chemist – QC – IAPI (QC eSystems) provides electronic system technical and compliance support for Indianapolis API Operations QC.  The Chemist – QC – IAPI is responsible for design and execution of laboratory computer validation initiatives, analytical method management, electronic notebook templates/scripting, and QC infrastructure requests. The Chemist – QC – IAPI will provide support for other support activities (i.e.: support, new equipment installation, data integrity, agency and internal inspections, system upgrades, change management, observation/deviation management, reviews, lean rollout, and related global initiatives).

Key Objectives/Deliverables:

  • Provide support for the implementation and maintenance of electronic notebooks

  • Subject matter expert 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. Aligns practices with internal and external regulatory requirements

  • 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 QC eSystems to improve business process productivity

Basic Requirements:

  • 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, Darwin, Empower and stand-alone laboratory instrument controllers)

Additional Preferences:

  • 4+ Years of QC experience with a focus on electronic lab notebooks, Computer System Validation (CSV) and instrument infrastructure.

Additional Information:

  • On-call support for 24hr operations is expected

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-15417.

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.

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