Senior QA Lead, Clinical Trial Packaging

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Medical benefits

Vacation benefits

Job summary

Lilly in Indianapolis is seeking a PR&D QA CT Packaging Engineer (R3-R4) to provide quality oversight for external packaging operations and partner with CPs to ensure compliant processes, systems, and documentation. The role demands strong collaboration across cross-functional teams and a quality-minded approach to improvements.

Responsibilities include reviewing quality records, supporting IQ/OQ/PQ reviews, investigations, CAPA tracking, and regulatory readiness for CP sites.

Qualifications

• Bachelor's degree in engineering (Packaging, Chemical, Mechanical, Industrial, or Materials Science) or related scientific discipline; equivalent R&D experience may substitute.
• 5+ years of experience in pharmaceutical or medical device manufacturing, packaging, or quality assurance in a cGMP environment.
• English language required; proficient technical writing and documentation skills.

Responsibilities

• Provide QA oversight of CP packaging operations, reviewing quality records and ensuring cGMP compliance.
• Assist in IQ/OQ/PQ reviews, packaging stability studies, and change control assessments at external sites.
• Lead/root cause investigations for deviations, support CAPA development and tracking, and participate in DRBs/CRBs as needed.
• Oversee material handling and control strategies at CP sites, including nude/unlabeled drug product.
• Contribute to quality risk assessments and maintain up-to-date knowledge of packaging regulations.
• Promote continuous improvement and support audits, inspections, and regulatory readiness.

Skills

Microsoft Office

QMS/eQMS experience

Technical writing

Education

Bachelor's degree in engineering or related science

Tools

SAP

TrackWise

eQMS platforms

Job description

Lilly in Indianapolis is seeking a PR&D QA CT Packaging Engineer (R3-R4) to provide quality oversight for external packaging operations and partner with CPs to ensure compliant processes, systems, and documentation. The role demands strong collaboration across cross-functional teams and a quality-minded approach to improvements.

Responsibilities include reviewing quality records, supporting IQ/OQ/PQ reviews, investigations, CAPA tracking, and regulatory readiness for CP sites.