Analyst – QC Chemistry & Device

Eli Lilly and Company • Research Triangle Park, NC

1d • Onsite

About The Position

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 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. Position Description The Analyst – QC Chemistry & Device performs accurate and timely laboratory testing and second person verification (SPV) of analytical data in accordance with applicable GMP, regulatory, and safety requirements to support site production and stability needs. This role is expected to operate with a high degree of independence and technical competence, combining hands-on analytical testing with critical review of laboratory data to ensure accuracy, completeness, and data integrity. The Analyst is responsible for maintaining training compliance, identifying and escalating atypical results or deviations, and actively supporting quality, compliance, and continuous improvement initiatives within the QC laboratory.

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.

Nice To Haves

• Experience supporting manufacturing or stability testing in a regulated environment.
• 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.
• Familiarity with Veeva Vault QMS (OneQMS) or similar electronic quality management systems.
• Strong attention to detail, communication, and organizational skills.
• Ability to work independently during off-shift hours and collaborate across shifts.
• Experience with lean lab and 5S concepts.

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.
• Adhere to all Environmental, Health, and Safety (EHS) standards and site policies.
• Serve as a reliable contributor on a small night-shift team, demonstrating accountability and sound judgment.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees