Associate, Quality Assurance, Manufacturing Operations

Eli Lilly and Company

Quality Assurance Associate supporting GMP manufacturing and startup operations at Lilly’s new Medicine Foundry. Reviewing quality documentation, investigations, and change controls for life-changing medicines.

Posted 8/4/2026full-timeIndianapolis • 🇺🇸 United StatesJuniorMid-Level💰 $65,250 - $169,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP operations, quality management systems, and compliance within the biotech or pharmaceutical industry. Capable of fostering a collaborative culture while effectively managing projects and communication across teams.

Highest-signal resume keywords

GMP Requirements UnderstandingQuality Management SystemsRoot Cause AnalysisProject Management SkillsBiotech Industry Experience

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GMP Documentation ReviewTechnical Report AnalysisChange Control ManagementInspection ReadinessProblem-Solving Skills

Soft Skills

Effective CommunicationTeamworkAttention to DetailTime ManagementFlexibility

Industry Keywords

FDA-Regulated IndustryCGMP FacilityBiotechPharmaceuticalQuality Assurance

About the role

Key responsibilities & impact

Support delivery of the Lilly Medicine Foundry during its design, construction, and startup phase
Help build a new organization and develop and implement systems and business processes for GMP operations
Help build the site culture as it grows into a full-scale GMP manufacturing facility
Provide day-to-day Quality Assurance oversight of GMP manufacturing operations after startup
Support change management and investigation reviews
Participate in creating and maintaining a safe work environment
Foster a collaborative quality culture through open communication, teamwork, and employee participation
Ensure compliance with applicable laws, regulations, and guidelines supporting GMP activities
Review GMP documentation, including procedures, deviations, technical reports, and change controls
Work cross-functionally with plant teams to provide operational support and issue management
Assist with inspection readiness activities
Communicate effectively with internal and external stakeholders
Provide on-call support outside normal working hours when required

Requirements

What you’ll need

BA/BS degree in Engineering, Science, or another related field
Minimum of 2 years of technical and/or quality experience in a biotech or pharmaceutical FDA-regulated industry
Understanding of GMP requirements for early-phase development and manufacturing
Understanding of quality management systems and their application
Must be authorized to work full-time in the United States
Lilly will not sponsor work authorization or visas
Effective project and time management skills
Ability to prioritize and handle multiple concurrent tasks
Problem-solving, verbal reasoning, attention to detail, critical thinking, and analytical competencies
Strong oral and written communication skills
Effective organization and self-management skills
Relevant experience in a cGMP facility preferred
Relevant industry experience in a high-paced working environment
Root cause analysis and troubleshooting skills
Flexibility to adapt to frequent changes and altered priorities
Ability to identify and prioritize issues and develop and implement solutions
High learning agility and ability to deal with ambiguity and uncertainty
Demonstrated attention to detail
Willingness and ability to provide on-call support outside normal working hours, including nights, weekends, and holidays, when required
Ability to travel 5%–15%

Benefits

Comp & perks

Company bonus depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits, including employee assistance program and fitness benefits
Employee clubs and activities
Employee resource groups and support networks