QA Operations Lead — GMP Startup Site

Lilly Group

Lebanon (IN)

On-site

USD 66,000 - 172,000

Full time

8 days ago
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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical/Dental/Vision insurance
Flexible benefits
Life insurance
Time off and leave
Well-being programs

Job summary

Lilly is building a state-of-the-art manufacturing site in Lebanon, Indiana, to support clinical and commercial supply for advanced therapies. The QA Operational Support Representative will ensure GMP compliance and lead quality activities across documentation, change control, investigations, and inspections.

The role requires a BS in a science/engineering field and 3+ years in pharmaceutical QA, with strong cross-functional collaboration and mentoring abilities to drive quality across the site.

Qualifications

  • Bachelor's degree in science/engineering/pharma or equivalent industry experience.
  • 3+ years in pharmaceutical manufacturing quality assurance.
  • Authorized to work in the United States on a full-time basis.

Responsibilities

  • Provide leadership and QA guidance for non-conformance investigations, change controls, and document reviews.
  • Oversee verification of equipment/facilities from requirements through testing.
  • Mentor operations staff on quality matters and data integrity.

Skills

Quality oversight
Regulatory compliance
Documentation practices
Data integrity
Cross-functional communication
Problem solving
Training/mentoring
Technical writing
Gene therapy familiarity

Education

Bachelor's degree in science/engineering/pharma

Tools

Kneat
Veeva Vault
SAP
Manufacturing execution systems
Microsoft Office

Job description

Lilly is building a state-of-the-art manufacturing site in Lebanon, Indiana, to support clinical and commercial supply for advanced therapies. The QA Operational Support Representative will ensure GMP compliance and lead quality activities across documentation, change control, investigations, and inspections.

The role requires a BS in a science/engineering field and 3+ years in pharmaceutical QA, with strong cross-functional collaboration and mentoring abilities to drive quality across the site.

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