Associate - QA Batch Disposition

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people who are determined to make life better for people around the world.

Lilly is entering an exciting period of growth and is committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company s manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations.

This is an exciting opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, highly integrated and automated manufacturing systems, and will focus on minimizing environmental impact.

The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility.

Electronic batch records with high integration and data integrity will be utilized to confirm manufacturing production.

• Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems
• Performs final batch disposition of semi-finished and/or finished drug product and combination product batches to ensure high quality medicine (GMP compliance) is released to market in a timely manner
• Effectively 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

• Bachelor s degree in STEM
• Experience working in the pharmaceutical or medical device industry in QA roles
• Previous batch disposition experience
• Ability to make technical decisions, provide guidance to the site
• 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
• Previous regulatory inspection readiness and inspection execution experience
• Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R4.

• Ability to work 8-hour days – Wednesday through Sunday Day Shift (not eligible for remote work)
• Ability to work overtime and be on-call as required
• Proven ability to work independently or as part of a team to resolve an issue
• Previous experience with Event and Change Management process
• Proficiency with SAP, MES, and Trackwise
• Previous experience with device and parenteral product materials

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