QA Representative - Warehouse

Position Overview

The Quality Assurance Representative for the Warehouse and Logistics teams provides daily oversight, assistance, and guidance to issues such as non‑conformance investigations, change control proposals, procedure revisions, validations, batch disposition, commissioning, and qualification activities for automated warehouse operations. This role reports directly to the Sr. Manager‑QA Materials and Logistics and is essential for maintaining GMP compliance and supporting inspections by regulatory agencies.

• Adhere to safety rules and maintain a safe work environment that supports corporate and site safety goals.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Maintain regular presence in warehousing areas, device assembly, and packaging areas to monitor GMP programs and quality systems.
• Participate in local cross‑functional teams focusing on warehousing, logistics, and supply‑chain matters.
• Provide quality support for third‑party warehouse locations that maintain RTP materials; assess and triage deviations, supplier or service provider issues.
• Work with internal support groups and external partners (including third‑party logistics) to resolve or provide advice on receiving, shipping, storage, or production supply issues.
• Participate in self‑led inspections and provide support during internal and external regulatory inspections.
• Effectively review and/or redline quality documents to ensure quality attributes are met (e.g., deviations, supplier complaints, procedures, technical studies, validation protocols, change controls, engineering documents).
• Approve commissioning, qualification, and validation documents for computer systems and equipment related to warehousing operations.
• Participate in Six Sigma projects focused on continuous improvement and productivity within the quality organization or cross‑functional teams.

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field.
• At least 2 years of quality experience supporting device, parenteral/drug substance products, or medical device industry in QA roles.
• Eligibility to work in the United States on a full‑time basis; please note Lilly will not sponsor work authorization or visas for this role.
• Proficiency with computer systems including Microsoft Office, inventory management systems, and deviation management systems (e.g., SAP, Veeva, Trackwise).

• Proven ability to work independently or as part of a team to troubleshoot and assess root causes.
• Strong attention to detail, decision making, and problem‑solving skills.
• Experience in GMP production environments and familiarity with manufacturing processes and quality systems.
• Prior experience in warehousing operations, ASRS warehousing, autonomous guided vehicles, and integrated systems.
• Experience with combination products or devices, US/EU regulations, and notified bodies.
• Certification(s) such as CQE, CQA, or CSQA from the American Society for Quality.
• Experience with facility or area start‑up activities.

• 8‑hour days Monday through Friday (Day Shift) with overtime and on‑call as needed.
• Ability to work in various areas within the PAR, DAP, and Warehouse buildings.
• Mobility requirements must be met.
• Position is at the Lilly Research Triangle Park site; during the project phase, flexibility for periodic remote work based on project and site activities.
• Travel up to 10% for 3PL locations or Indianapolis, IN for meetings and coordination with global regulatory organizations.

Anticipated annual wage: $65,250 – $169,400, depending on education, experience, and location. Full‑time employees are eligible for company bonus, 401(k) with company match, pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits, life and death insurance, and well‑being programs.

Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.