Associate, Quality Assurance, Manufacturing Operations

Eli Lilly and Company

. Participate in creating and maintaining a safe work environment .

Posted 10/8/2026full-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 compliance, quality management systems, and technical problem-solving within a biotech or pharmaceutical environment. Capable of effective communication, project management, and fostering a collaborative quality culture.

Highest-signal resume keywords

GMP ComplianceQuality Management SystemsTechnical Problem-SolvingProject ManagementEffective Communication

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 ReviewChange ManagementRoot Cause AnalysisTroubleshootingInspection ReadinessAnalytical CompetenciesAttention to DetailTechnical Reports ReviewDeviation ManagementQuality Oversight

Soft Skills

CollaborationTime ManagementFlexibilityCritical ThinkingSelf-Management

Industry Keywords

Biotech IndustryPharmaceutical IndustryFDA RegulationsCGMP FacilityHigh-Paced Working Environment

About the role

Key responsibilities & impact

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
During the startup phase, support delivery of the Lilly Medicine Foundry, build the new organization, develop and implement systems and business processes for GMP operations, and build site culture
After startup, provide day-to-day production-floor QA support, quality oversight of GMP operations, change management, and investigation reviews
Provide on-call support outside normal working hours, including nights, weekends, and holidays, as required
Travel 5%–15%

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 and application of quality management systems
Authorized to work in the United States on a full-time basis; Lilly will not provide work authorization or visa sponsorship
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
Relevant industry experience in a high-paced working environment
Technical problem-solving skills, including root cause analysis and troubleshooting
Flexibility to adjust 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

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and 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, fitness benefits, and employee clubs and activities