QA Batch Disposition

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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Description:
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and be a member of the Quality Assurance disposition team. 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 Quality Assurance Representative has oversight for the disposition of incoming materials, components, final disposition of semi-finished and/or finished drug combination products. As the authorized quality representative, serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.

Responsibilities:

• Review related batch records associated with parenteral manufacture, semi-finished devices, and final packaged product.
• Performs final batch disposition of raw materials, components, active pharmaceutical ingredient (API), semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
• Lead, mentor and coach site personnel on quality matters associated with the batch or batch disposition process.
• 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 Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Requirements:

• Bachelors or equivalent (Science or Engineering related degree preferred).
• At least 5 years working in the pharmaceutical or medical device industry in QA roles.
• Previous batch disposition experience supporting device, parenteral or drug substance products/materials.

Additional Skills/Preferences:

• Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS; such as, Darwin or similar), Deviation Management Systems (TrackWise).
• Demonstrated relevant experience in a GMP facility.
• Ability to make technical decisions, provide guidance to the site and lead others.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous regulatory inspection readiness and inspection execution experience.
• Ability to work overtime as required.
• CQA certification from the American Society for Quality (ASQ)

Additional Information:

• Position is day shift and includes the requirement to work rotating weekends.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
• The position is for the Lilly Research Triangle Park site and will allow for a flexible working environment with the ability to periodically work remotely based on site activities.
• 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 this employment position.

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Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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