Chemist - QC - IAPI (eSystems)

Eli Lilly - Indianapolis, IN

Full-time - Entry Level

Indianapolis, IN

Chemical Manufacturing

About the position

The Chemist - QC - IAPI (QC eSystems) at Lilly plays a crucial role in providing electronic system technical and compliance support for the Indianapolis API Operations Quality Control (QC) department. This position is responsible for the design and execution of validated computer systems, managing analytical methods, and developing electronic notebook templates and scripting. The Chemist will also be involved in various support activities, including new equipment installation, ensuring data integrity, and preparing for agency and internal inspections. The role requires a proactive approach to system upgrades, change management, and managing observations and deviations, all while aligning with global initiatives. Key objectives for this position include supporting the implementation and maintenance of electronic notebooks, serving as a subject matter expert for laboratory computer system audits, and conducting validation and periodic reviews. The Chemist will interact effectively with business partners to communicate and resolve issues, ensuring a clear understanding of requirements. Additionally, the role involves understanding the direction of technology and its impact on laboratory business processes, quality systems, and the QC organization. The Chemist will implement programs and processes that enhance compliance and quality within the QC laboratories, as well as train and mentor analysts through formal processes. The Chemist will assess, review, and author change controls and deviations for electronic systems and QC instrumentation. Utilizing technical skills, the Chemist will lead or perform in-depth investigations affecting data integrity, drawing conclusions and performing root cause analysis to recommend solutions that prevent recurrence. The role also requires supporting laboratory infrastructure and acting as a liaison between QC and the IT organization, particularly in areas such as instrument interfacing, data archiving, and technology infrastructure. Evaluating new laboratory technologies for their impact on the QC systems portfolio and providing direction in the qualification of new equipment technologies are also key responsibilities. Finally, the Chemist will work to improve laboratory quality systems by developing content, reviewing, and approving standard operating procedures (SOPs) and training as necessary, while influencing business areas to understand their processes and identify opportunities for improvement.

Responsibilities

• Provide support for the implementation and maintenance of electronic notebooks.
• Serve as a subject expert for laboratory computer system audit activities, validation, and periodic reviews.
• Interact effectively with business partners to communicate and resolve issues and gain a clear understanding of requirements.
• Understand the direction of technology and its impact on laboratory business processes, quality systems, and the QC organization.
• Implement programs/processes to improve overall compliance and quality in the QC Laboratories.
• Train and mentor analysts through formal processes/programs.
• 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.
• Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent recurrence.
• Support laboratory infrastructure and act as a liaison between QC and the IT organization.
• Evaluate new laboratory technologies for impact on other QC systems and provide direction in qualification of new equipment technologies.
• Improve laboratory quality systems; develop content, review, and approve SOPs and training as necessary.
• Influence business areas' understanding of their own business processes and identify new opportunities.

Requirements

• Bachelor's Degree 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.
• 4+ years of QC experience with a focus on electronic lab notebooks and instrument infrastructure.
• Deep understanding of laboratory quality systems and their dependencies (e.g., TrackWise, SmartLab, Darwin, Empower, NuGenesis, and instrument controlling laboratory systems).
• Proficiency with computer systems and operating systems.
• Strong oral, written communication, and interpersonal interaction skills.

Nice-to-haves

• Experience with laboratory computer system audit activities.
• Knowledge of data integrity principles and practices.
• Familiarity with regulatory compliance in a laboratory setting.

Benefits

• Health insurance coverage.
• Dental insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Professional development opportunities.
• Employee resource groups for support and networking.