QA Associate, GMP Manufacturing Operations

100 Eli Lilly and Company

Lebanon (IN)

On-site

USD 65,000 - 169,000

Full time

3 days ago
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Job summary

Lilly is seeking a Quality Assurance Associate, Manufacturing Operations in Indianapolis, IN to support GMP operations during startup and ongoing production. The role focuses on quality oversight, change management, and investigation reviews on the manufacturing floor.

The position emphasizes collaboration with plant teams, cross-functional partners, and effective communication, with start-up activities in the Medicine Foundry project and potential relocation alignment to Lebanon, IN as needed.

Qualifications

  • 2 years of technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
  • Understanding GMP requirements for early phase development and manufacturing.
  • Authorized to work in the United States on a full-time basis.

Responsibilities

  • Create and maintain a safe work environment.
  • Foster a collaborative quality culture and promote teamwork across cross-functional teams.
  • Ensure compliance with laws, regulations, and GMP guidelines.
  • Review GMP documentation including procedures, deviations, and change controls.
  • Work cross-functionally with plant teams to provide operational support and issue management.
  • Assist with inspection readiness activities.
  • Communicate effectively with internal and external stakeholders.

Skills

Quality experience
GMP knowledge
Cross-functional collaboration
Inspection readiness

Education

BA/BS in Engineering or Science

Job description

Lilly is seeking a Quality Assurance Associate, Manufacturing Operations in Indianapolis, IN to support GMP operations during startup and ongoing production. The role focuses on quality oversight, change management, and investigation reviews on the manufacturing floor.

The position emphasizes collaboration with plant teams, cross-functional partners, and effective communication, with start-up activities in the Medicine Foundry project and potential relocation alignment to Lebanon, IN as needed.

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