The Quality Assurance Batch Disposition Representative assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Device Assembly and Packaging activities.

The QA Batch Disposition Representative is responsible for disposition of Incoming Materials, Semi-Finished and/or Finished drug products.

The QA Batch Disposition Representative provides guidance to process team members for Batch related issues, such as non - conformance investigations, issue resolution, and other batch disposition activities.

Key Objectives

Deliverables:

• Performs batch disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely

manner.

• Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Batch / Batch Disposition.
• Provides guidance in operational areas to ensure robust Quality Systems

and GMP compliance.

• Participate in self -led inspections and/or provide support during internal/external regulatory inspections.
• Effectively review/approve GMP documents to ensure quality attributes are met (i.e. Non-conformances, procedures, protocols, specifications, and change controls).
• Participates in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.

Minimum Requirements:

• Bachelor's degree OR minimum 5 years experience in pharmaceutical, regulatory, or quality environment

Additional Preferences:

• Demonstrated relevant experience in a GMP facility.
• Proficiency with applicable computer systems.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Proven ability to work independently or as part of a team to resolve an issue.
• Previous experience with Lilly Event and Change Management process.
• Proficiency with SAP, MES (PMX), and Darwin.
• Previous experience in QC or QA is desirable.