QA Operations Lead – GMP Start-Up Manufacturing

Regulatory Jobs; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Company bonus

401(k) and benefits

Job summary

Lilly’s Indianapolis/Lebanon site is seeking a QA Operational Support Representative to uphold GMP, guide change control, and support inspections. You will oversee documentation, equipment verification, and batch release for clinical and commercial supply, driving quality through cross-functional collaboration.

Ideal candidates have 3+ years in pharma QA, US work authorization, and ASQ certification. The role offers a comprehensive benefits package and a strong focus on patient outcomes.

Qualifications

• Bachelor's degree in science/engineering/pharma or equivalent.
• 3+ years QA experience in pharma manufacturing.
• Authorized to work in the United States full-time.
• ASQ Certification preferred

Responsibilities

• Adhere to safety rules and maintain a safe work environment.
• Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures.
• Oversee verification of manufacturing equipment/facilities from definition of requirements thru design and testing.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Support the definition and execution of inspection readiness activities and provide support for internal / external regulatory inspections.
• Lead/support Process Team initiatives needed in support of the Site and Quality function.
• Ensure regular presence in operational areas to monitor GMP programs and quality systems.
• Provide guidance and triage for deviations and change controls.
• Support and/or execute review of batch records and release of drug substance, drug product, and finished product batches for Clinical Trial and commercial use.
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach to facility delivery and operation

Skills

Quality systems

Data integrity

Regulatory compliance

Technical writing

Cross-functional communication

Education

Bachelor's degree in science/engineering/pharma

Tools

Kneat

Veeva Vault

SAP

MES

Microsoft Office

Job description

Lilly’s Indianapolis/Lebanon site is seeking a QA Operational Support Representative to uphold GMP, guide change control, and support inspections. You will oversee documentation, equipment verification, and batch release for clinical and commercial supply, driving quality through cross-functional collaboration.

Ideal candidates have 3+ years in pharma QA, US work authorization, and ASQ certification. The role offers a comprehensive benefits package and a strong focus on patient outcomes.