Sr. Associate, QA Analytical; R2 – R3

Responsibilities

• Provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners.
• Ensure quality oversight for molecule testing labs and analytical equipment.
• Perform audits, lab walkthroughs, assessments of quality documentation and data.
• Ensure quality systems are implemented, used, and controlled.
• Facilitate quality improvement initiatives and implementation of new quality standards.
• Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out‑of‑specification results.
• Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations.

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field.
• Minimum 4 years experience with quality assurance and control in a pharmaceutical setting.
• At least 1 year of experience conducting comprehensive document reviews (including manufacturing batch records, QC methods, protocols, reports, and validation documents).
• At least 1 year of experience reviewing and approving method validation and technology transfer documents in compliance with ICH and FDA guidance.
• At least 1 year of experience reviewing logbooks, QA batch disposition, and QA support.
• At least 1 year of experience supporting QA for contract manufacturing organizations.
• At least 1 year of experience reviewing and supporting QA equipment validation documents (IQ, OQ, PQ) and maintenance and calibration of equipment.
• Up to 10% domestic and international travel.

Indianapolis, IN.

Annual salary range: $ – $.

Full‑time employees are eligible for a company bonus, 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, leave, and well‑being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.