Senior Quality Assurance Specialist - API External Manufacturing(Pharmaceutical)

Lilly; Indianapolis (IN); On-site; USD 100,000 - 170,000; Full time

Job summary

Lilly seeks a Senior/Principal Associate QA for API External Manufacturing to provide quality oversight for contract manufacturing organizations in a GMP environment. You will review and approve batch records, deviations, CAPAs, and change controls; support regulatory inspections; and ensure compliance with global quality and regulatory standards.

You will partner closely with external suppliers and internal technical teams to manage risks, drive continuous improvement, and ensure reliable

Qualifications

• Review and approve batch records, deviations, CAPAs, and change controls.
• Support regulatory inspections and ensure compliance with global quality and regulatory standards.
• Partner with external suppliers and internal teams to manage risk and drive continuous improvement.

Responsibilities

• Provide quality oversight for contract manufacturing organizations within a GMP environment.
• Review quality system records and close out quality events.
• Collaborate with Lilly and external partners to ensure reliable API supply and compliant manufacturing.

Skills

QA Oversight

GMP Compliance

CAPA Management

Batch Records Review

Job description

Lilly seeks a Senior/Principal Associate QA for API External Manufacturing to provide quality oversight for contract manufacturing organizations in a GMP environment. In this role, you will review and approve batch records, deviations, CAPAs, and change controls, support regulatory inspections, and ensure compliance with global quality and regulatory standards. You will partner closely with external suppliers and internal technical teams to manage risks, drive continuous improvement, and ensure reliable supply of high‑quality APIs that support Lilly’s global portfolio and patient needs.