QA Representative - Warehouse

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe tackle complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people worldwide by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. In addition to breakthrough medications, we also develop creative solutions to support communities through philanthropy and volunteerism. The Lilly RTP warehouse is a fully automated system with pallet conveyors, pallet exchangers, an automated storage and retrieval system (ASRS), and autonomous guided vehicle (AGV) delivery of materials to the line. The Quality Assurance Representative for the Warehouse and Logistics teams provides daily oversight, assistance, and guidance on non‑conformance investigations, change control proposals, procedure revisions, validations, batch disposition, commissioning, and qualification activities, focusing on automated warehouse operations. This role reports directly to the Sr. Manager‑QA Materials and Logistics. Key Objectives/Deliverables Adhere to safety rules and maintain a safe work environment for self and others, supporting corporate and site safety goals. Lead, mentor, and coach operations and support personnel on quality matters. Maintain regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs and quality systems. Participate in local cross‑functional teams focused on warehousing, logistics, third‑party 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 within the warehouse, logistics, supply chain, or third‑party logistics areas. Work with Lilly support groups and external partners (including third‑party logistics) to resolve or advise on receiving, shipping, storage, or production supply issues. Participate in self‑led inspections and provide support during internal and external regulatory inspections. Effectively review or redline documentation to ensure quality attributes are met (e.g., deviations, supplier complaints, procedures, technical studies, validation protocols, change controls, and engineering documents). Approve commissioning, qualification, and validation documents for computer systems and equipment related to warehousing operations, ensuring compliance with quality standards. Participate in Six Sigma projects focused on continuous improvement and productivity within the quality organization or cross‑functional teams. Basic Requirements Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field. At least 2 years of prior quality experience supporting devices, parenteral/drug substance products, or materials in QA roles. Applicant must be authorized to work in the United States on a full‑time basis; no visa sponsorship will be provided. Proficiency with computer systems including Microsoft Office, inventory management systems, and deviation management systems (e.g., SAP, Veeva, Trackwise). Preferred Attributes (Not Required) Ability to work independently or as part of a team to troubleshoot and assess root cause. Strong attention to detail. Excellent oral, written, and interpersonal communication skills. Demonstrated decision‑making and problem‑solving skills. Previous experience in GMP production environments. Knowledge and understanding of manufacturing processes and quality systems. Experience in warehousing operations. Experience with ASRS warehousing, autonomous guided vehicles, and integrated systems. Experience with combination products or devices and knowledge of US/EU regulations and notified bodies. Certifications such as CQE or CQA from the American Society for Quality. Computer Systems Quality (CSQA) experience. Experience with facility or area start‑up. Additional Information Work 8‑hour days Monday through Friday (day shift). Ability to work overtime and be on‑call as needed. Mobility requirements may be considered. Positions may require frequent travel up to 10% to third‑party locations or Indianapolis, IN. Flexible working environment with occasional remote work during certain project phases. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form to request an accommodation as part of the application process. Lilly is proud to be an 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. Benefits Full‑time employees are eligible for a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug coverage; flexible benefits options; life and death insurance; certain time‑off and leave of absence benefits; and well‑being benefits such as employee assistance programs, fitness benefits, and employee clubs and activities. Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. #J-18808-Ljbffr Initial Therapeutics, Inc.