Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

Lilly • Indianapolis, IN

9d • $65,250 - $169,400 • Hybrid

About The Position

Lilly recently announced a $4.5 billion investment to build the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. This facility, the first of its kind, will integrate research and manufacturing to optimize processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact. The Foundry is currently in the design and construction phase, with startup anticipated for completion in 2027. The initial role will be dynamic, supporting the Foundry's delivery, organizational development, system implementation for GMP operations, and site culture building. This requires collaboration, creativity, and resilience. Once startup activities are complete, the Quality Assurance Associate, Manufacturing Operations role will provide QA support on the production floor, including daily oversight of GMP operations, change management, investigation reviews, and other assigned tasks.

Requirements

• BA/BS degree in Engineering, Science, or other related field and a minimum of 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry
• Understand GMP requirements for early phase development and manufacturing and in application of quality management systems.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Effective project and time management skills.
• Demonstrated ability to prioritize and handle multiple concurrent tasks.
• Cognitive abilities, which include problem solving, verbal reasoning, attention detail, critical thinking and analytical competencies.
• Demonstrated strong oral and written communication skills.
• Effective organization/self-management skills
• Demonstrated relevant experience in a cGMP facility.
• Relevant industry experience in high paced working environment.
• Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
• Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
• Ability to identify and prioritize issues and develop & implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Demonstrated attention to detail.

Responsibilities

• Participate in creating and maintaining a safe work environment.
• Foster a strong collaborative quality culture including maintaining open communication and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
• Review GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross-functionally with the plant teams to provide operational support, and issue management.
• Assist with inspection readiness activities.
• Effectively communicate with internal and external stakeholders.

Benefits

• 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 (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level