Associate - QA Batch Disposition

Job Responsibilities

• Assures patients worldwide of safe and efficacious drug and device products through effective quality oversight of site activities.
• Final disposition of Semi-Finished and/or Finished drug combination products.
• Essential for ensuring GMP compliance in the qualification, validation, control strategy, and startup of operations to ensure regulatory approval of the facility.
• Supports 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 owns/reviews/approves GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls).

Basic Requirements

• Bachelor’s degree in STEM
• Experience working in the pharmaceutical or medical device industry in QA roles
• Batch disposition experience
• Technical decision-making and guidance capabilities
• Proficiency with applicable computer systems
• Strong oral and written communication skills
• Interpersonal skills and teamwork abilities
• Root cause analysis/troubleshooting skills
• Attention to detail and quality system maintenance
• Regulatory inspection readiness and execution experience
• Ability to work 8-hour days (Wednesday through Sunday), Day Shift, and be on-call as required

Additional Skills/Preferences

• Ability to work independently or as part of a Team to resolve issues
• Proven ability with Event and Change Management processes
• Proficiency with SAP, MES, and Trackwise
• Previous experience with device and parenteral product materials
• Ability to work 10% for meetings and coordination with global or existing manufacturing sites

Organization Overview

Lilly is entering an exciting period of growth and is committed to delivering innovative medicines to patients around the world. The company 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 once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.