Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking a Quality Assurance Associate for Manufacturing Operations to provide day-to-day QA oversight on GMP operations, change controls, and investigations on the production floor. The role emphasizes safe, compliant manufacturing and collaborative problem solving.

Initial location is Indianapolis, IN, with potential future site in Lebanon, IN. Travel expected 5–15%. On-call support nights/weekends/holidays may be required.

Qualifications

• BA/BS in Engineering, Science, or related field.
• Minimum 2 years in Biotech or Pharmaceutical FDA-regulated industry.
• Authorized to work in the United States; Lilly sponsorship not provided.

Responsibilities

• Participate in creating and maintaining a safe work environment.
• Foster a collaborative quality culture with cross-functional teams.
• Ensure GMP compliance across activities.
• Review GMP documentation including deviations and change controls.
• Work cross-functionally with plant teams for operational support and issue management.
• Assist with inspection readiness activities.
• Communicate effectively with internal and external stakeholders.

Skills

Quality Assurance

GMP knowledge

Documentation review

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Job description

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.