Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

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.

• 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.

• 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.

• 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.

• Initial location:
  Indianapolis, IN; future:
  Lebanon, IN (Lilly Medicine Foundry Operations). Travel: 5–15%. On-call support may be required nights/weekends/holidays.