Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry
Eli Lilly and Company
August 26, 2026
On-site
Indianapolis, IN
Operations
Organization and Position Overview
- Quality Assurance Associate, Manufacturing Operations role supporting manufacturing production floor QA functions, including day-to-day Quality oversight of GMP operations, change management, and investigation reviews.
Responsibilities
- Participate in creating and maintaining a safe work environment.
- Foster a collaborative quality culture with open communication and teamwork (including cross-functional teams).
- Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
- Review GMP documentation (procedures, deviations, technical reports, change controls, etc.).
- Work cross-functionally with plant teams for operational support and issue management.
- Assist with inspection readiness activities.
- Communicate effectively with internal and external stakeholders.
Basic Requirements
- BA/BS in Engineering, Science, or related field; minimum 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
- Understand GMP requirements for early phase development/manufacturing and quality management systems.
- Authorized to work in the United States full-time; Lilly does not provide sponsorship/visa support.
Additional Preferences
- Project/time management; prioritize multiple concurrent tasks.
- Problem solving, verbal reasoning, attention to detail, critical thinking, analytical skills.
- Strong oral and written communication; organization/self-management.
- Relevant cGMP facility experience; high-paced environment experience.
- Root cause analysis/troubleshooting; flexibility to change priorities; identify/prioritize issues and implement solutions.
- High learning agility; ability to work with ambiguity; demonstrated attention to detail.
Other Information
- Initial location: Indianapolis, IN; future: Lebanon, IN (Lilly Medicine Foundry Operations). Travel: 5–15%. On-call support may be required nights/weekends/holidays.
- Quality Assurance Associate, Manufacturing Operations role supporting manufacturing production floor QA functions, including day-to-day Quality oversight of GMP operations, change management, and investigation reviews.
Responsibilities
- Participate in creating and maintaining a safe work environment.
- Foster a collaborative quality culture with open communication and teamwork (including cross-functional teams).
- Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
- Review GMP documentation (procedures, deviations, technical reports, change controls, etc.).
- Work cross-functionally with plant teams for operational support and issue management.
- Assist with inspection readiness activities.
- Communicate effectively with internal and external stakeholders.
Basic Requirements
- BA/BS in Engineering, Science, or related field; minimum 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
- Understand GMP requirements for early phase development/manufacturing and quality management systems.
- Authorized to work in the United States full-time; Lilly does not provide sponsorship/visa support.
Additional Preferences
- Project/time management; prioritize multiple concurrent tasks.
- Problem solving, verbal reasoning, attention to detail, critical thinking, analytical skills.
- Strong oral and written communication; organization/self-management.
- Relevant cGMP facility experience; high-paced environment experience.
- Root cause analysis/troubleshooting; flexibility to change priorities; identify/prioritize issues and implement solutions.
- High learning agility; ability to work with ambiguity; demonstrated attention to detail.
Other Information
- Initial location: Indianapolis, IN; future: Lebanon, IN (Lilly Medicine Foundry Operations). Travel: 5–15%. On-call support may be required nights/weekends/holidays.