Associate - QA Batch Disposition

Job Responsibilities:
- Support the site in the development and execution of the site readiness plan, including the site e-release process and startup of new systems
- Perform final batch disposition of semi-finished and/or finished drug product and combination product batches to ensure GMP-compliant release to market in a timely manner
- Own/review/approve GMP documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications, and change controls)
- Additional job duties as required

Basic Requirements:
- Bachelor’s degree in STEM
- Experience in pharmaceutical or medical device industry QA roles
- Previous batch disposition experience
- Ability to make technical decisions and provide guidance to the site
- Proficiency with applicable computer systems
- Strong oral and written communication skills; interpersonal skills and teamwork
- Root cause analysis/troubleshooting skills
- Attention to detail; ability to maintain quality systems
- Previous regulatory inspection readiness and inspection execution experience
- Ability to travel up to 10%
- Ability to maintain a safe work environment and support HSE goals
- Legally authorized to work in the United States; no visa sponsorship anticipated for certain paths/levels

Additional Skills/Preferences:
- 8-hour days, Wednesday–Sunday day shift; not eligible for remote work
- Ability to work overtime and be on-call
- Independent and/or team-based issue resolution
- Experience with Event and Change Management
- Proficiency with SAP, MES, and Trackwise
- Experience with device and parenteral product materials

Benefits (explicitly stated):
- Company bonus (depending on performance)
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits

Application Instructions:
- If you require accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation