Analyst - QC Chemistry & Device

21h21 hours ago

Eli Lilly and Company

US · Full-time · $65,250 – $169,400

About this role

At Lilly, a global healthcare leader headquartered in Indianapolis, we unite caring with discovery to make life better for people around the world. The Analyst – QC Chemistry & Device performs accurate and timely laboratory testing and second person verification (SPV) of analytical data in accordance with GMP, regulatory, and safety requirements to support site production and stability needs. This role demands a high degree of independence and technical competence.

Daily responsibilities include hands-on analytical testing combined with critical review of laboratory data to ensure accuracy, completeness, and data integrity. Analysts accurately record, review, and interpret data in systems like LIMS while executing techniques such as HPLC, UV-Vis, Capillary Electrophoresis, device testing, and utilities testing. They proactively identify deviations, atypical results, or out-of-trend data and support investigations.

The role operates within a QC laboratory environment focused on quality, compliance, and continuous improvement initiatives. Analysts maintain training compliance, adhere to EHS standards, and serve as reliable contributors on a small night-shift team, demonstrating accountability and sound judgment. Minimal supervision is expected in this regulated setting.

Opportunities involve troubleshooting methods and equipment, authoring SOPs, protocols, and quality documentation like investigations, deviations, and CAPAs. This position supports manufacturing or stability testing while fostering skills in data integrity and cGMP standards. Contribute to making life-changing medicines for those in need.

Requirements

Bachelor’s degree (4-year college) in Chemistry, Biology, Microbiology, or a related scientific discipline
Demonstrated experience in a GMP QC laboratory environment, including routine analytical testing and data documentation
Experience performing work with minimal supervision in a regulated laboratory setting
Experience with LIMS and Empower
Hands-on experience with HPLC, CE, device testing, and compendial methods
Experience performing second person verification (SPV)
Working knowledge of FDA regulations, cGMP, and compendial requirements
Experience participating in laboratory investigations, root cause analysis, and CAPA activities

Responsibilities

Independently perform accurate and timely analytical testing of routine laboratory and stability samples in accordance with approved procedures, protocols, and GMP requirements
Perform second person verification (SPV) and peer review of analytical data, ensuring compliance with data integrity, cGMP, and site quality standards
Accurately record, review, and interpret analytical data in laboratory systems (e.g., LIMS) in accordance with laboratory procedures and GMP requirements
Execute laboratory testing techniques including HPLC, UV-Vis, Capillary Electrophoresis (CE), device testing, compendial testing, and utilities testing (e.g., TOC, nitrates)
Proactively identify deviations, atypical results, or out-of-trend data and initiate or support laboratory investigations as required
Author, review, and close analytical investigations, deviations, change controls, CAPAs, and other quality documentation as applicable
Troubleshoot analytical methods and laboratory equipment with minimal supervision
Author, revise, and review SOPs, protocols, and other controlled laboratory documents