External Manufacturing QA – Documentation & Compliance Lead

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

Job summary

Lilly in Indianapolis invites applications for an EM Quality Assurance QA Representative. This role oversees the global quality standards for documentation and data integrity, coordinating with Drug Product External Manufacturing and API teams to ensure GMP compliance and audit readiness.

The position focuses on SOP maintenance, training design, and contributing to cross-functional quality initiatives, with occasional travel and a day shift.

Qualifications

• Bachelor's Degree in a science related field.
• 2+ years of hands-on GMP-regulated pharmaceutical experience with document control or quality systems.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Provide oversight of departmental document management systems and data integrity initiatives.
• Serve as liaison between L&D and EM for documentation and training.
• Lead implementation of quality document initiatives and drive process improvements.

Skills

Teamwork

Independent work

Computer systems

Education

Bachelor's Degree in science-related field

Tools

Trackwise

QDocs

ServiceNow

SuccessFactors

Job description

Lilly in Indianapolis invites applications for an EM Quality Assurance QA Representative. This role oversees the global quality standards for documentation and data integrity, coordinating with Drug Product External Manufacturing and API teams to ensure GMP compliance and audit readiness.

The position focuses on SOP maintenance, training design, and contributing to cross-functional quality initiatives, with occasional travel and a day shift.