QA Associate, GMP Manufacturing Operations

Regulatory Jobs; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly in Indianapolis is hiring a Quality Assurance Associate, Manufacturing Operations to support GMP operations on the Lilly Medicine Foundry startup. You will perform day-to-day QA oversight on manufacturing processes, participate in change controls and investigations, and help build the systems and culture needed for a new, scale-up facility.

The role requires a BA/BS in Engineering or Science with 2 years of biotech or pharmaceutical QA experience, GMP knowledge, and the ability to work

Qualifications

• BA/BS in Engineering, Science or related field with minimum 2 years QA/technical experience.
• Understanding of GMP requirements for early phase development and manufacturing.
• Authorized to work in the United States full-time; Lilly will not sponsor visas.

Responsibilities

• Participate in creating and maintaining a safe work environment.
• Foster a strong collaborative quality culture including open communication and teamwork across functions.
• Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
• Review GMP documentation including procedures, deviations, technical reports, and change controls.
• Work cross-functionally with plant teams to provide operational support and issue management.
• Assist with inspection readiness activities.
• Effectively communicate with internal and external stakeholders.

Skills

QA experience

GMP knowledge

Regulatory compliance

Education

BA/BS in Engineering or Science

Job description

Lilly in Indianapolis is hiring a Quality Assurance Associate, Manufacturing Operations to support GMP operations on the Lilly Medicine Foundry startup. You will perform day-to-day QA oversight on manufacturing processes, participate in change controls and investigations, and help build the systems and culture needed for a new, scale-up facility.

The role requires a BA/BS in Engineering or Science with 2 years of biotech or pharmaceutical QA experience, GMP knowledge, and the ability to work