QA Batch Disposition Specialist – GMP & Site Readiness

Eli Lilly and Company; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly Concord is seeking a Quality Assurance Batch Disposition professional to ensure safe, efficacious drug and device products through GMP oversight and accurate final disposition of batches. The role emphasizes data integrity, site readiness, and collaboration across QA and manufacturing teams.

The position requires a STEM Bachelor’s degree, experience in pharmaceutical/medical device QA, batch disposition expertise, strong communication, and the ability to travel up to 10% for coordination

Qualifications

• 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.

Responsibilities

• 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 (i.e.: Deviations, procedures, protocols, specifications, and change controls).
• Additional job duties as required.

Skills

Oral and written communication

Interpersonal skills

Team collaboration

Decision making

Technical guidance

Attention to detail

Troubleshooting

Education

Bachelor's degree in STEM

Tools

SAP

MES

Trackwise

Job description

Lilly Concord is seeking a Quality Assurance Batch Disposition professional to ensure safe, efficacious drug and device products through GMP oversight and accurate final disposition of batches. The role emphasizes data integrity, site readiness, and collaboration across QA and manufacturing teams.

The position requires a STEM Bachelor’s degree, experience in pharmaceutical/medical device QA, batch disposition expertise, strong communication, and the ability to travel up to 10% for coordination