QA Associate Job at Lilly – Pharma Quality in Indianapolis – Apply Now!
Are you ready to contribute to life-changing medicines and world-class quality systems? Lilly, a global healthcare leader, is hiring a QA Associate for QC to oversee laboratory quality and compliance at External Manufacturing (CM) sites in Indianapolis, Indiana. This full-time role offers the opportunity to lead analytical method validations, stability programs, and GMP documentation while ensuring external labs meet Lilly’s high standards. If you have a background in Pharma QC and cGMP, this could be the ideal next step in your quality career.
About Lilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Position Details:
| Job Title | QA Associate – QC (Drug Product External Manufacturing) |
|---|---|
| Job Role | Quality oversight for external labs, method validation, compliance, and documentation |
| Location | Indianapolis, Indiana, USA |
| Work Type | Full-Time, Regular |
| Shift | Primarily Day Shift (flexibility required) |
| Travel | Up to 30% |
| Workplace | Minimum 4 days/week onsite |
| Job ID | R-87687 |
QA Associate Job Overview
As a QA for QC Representative, you will serve as the primary quality liaison for laboratory-related activities at external manufacturing sites. This role is critical in maintaining GMP compliance, supporting regulatory inspections, and ensuring successful product launches.
Key Responsibilities
Laboratory Oversight & Quality Leadership
- Provide quality oversight and guidance for CM laboratory operations.
- Lead or support lab-related activities for new product, package, or CM launches.
- Drive improvements in CM lab quality systems through technical leadership.
Compliance & Documentation
- Ensure CM labs maintain a state of control and are inspection-ready at all times.
- Conduct SOP assessments and track the resolution of outstanding issues.
- Participate in and support regulatory inspections and internal audits.
Collaboration & Communication
- Build strong relationships with CM lab personnel and internal Lilly teams.
- Serve as a key member of Joint Process Teams (JPTs), providing lab-related insights and support.
- Partner with Lilly support groups to resolve product-related issues.
Basic Qualifications for QA Associate Job
Bachelor’s degree in Biological Sciences, or a STEM-related degree. Minimum 3 years of experience in pharmaceutical Quality Control within a GMP-regulated lab environment.
Preferred Qualifications
- Experience with electronic quality systems.
- Familiarity with Microbiology/Sterility Testing and product stability programs.
- Strong project management, coaching, and mentoring skills.
Keywords: Lilly, QA Associate, Drug Product, External Manufacturing, Indianapolis, Quality Control, GMP, Pharmaceutical, QA Associate Job
