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 take on 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 around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Lilly RTP warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line. The Quality Assurance Representative for the Warehouse and Logistics teams provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities, with a focus on Automated Warehouse operations. This role reports directly to the Sr. Manager- QA Materials and Logistics. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.
Key Objectives/Deliverables:
Responsible for adhering to safety rules and maintaining a safe work environment for both self and others by supporting safety corporate and site goals.
Lead, mentor, and coach operations and support personnel on quality matters.
Ensure regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs, and quality systems.
Active on local cross-functional teams with focus on Warehousing. Logistics, 3rd party logistics and supply chain matters.
Provide quality support with third-party warehouse locations that maintain RTP materials.
Ability to assess and triage deviations, supplier or service provider issues that occur within the warehouse, logistics, supply chain or 3rd party logistics areas.
Work with Lilly support groups and external partners (including 3rd 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 / external regulatory inspections.
Effectively review and / or redline to ensure quality attributes are met. (i.e, deviations, supplier complaints, procedures, technical studies, validation protocols, change controls, and engineering documents).
Approve commissioning qualification / validation documents for computer systems and equipment related to the warehousing operations, to ensure 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 of study.
2+ years previous quality experience supporting device, parenteral/drug substance products/materials, or medical device industry in QA roles.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Veeva, Trackwise, etc.)
Preferred Attributes Not Required:
Proven ability to work independently or as part of a team to troubleshoot and assess root cause.
Strong attention to detail.
Demonstrated strong oral, written and interpersonal communication skills.
Demonstrated decision making and problem-solving skills.
Previous experience in GMP production environments.
Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
Previous experience in warehousing operations.
Previous experience with ASRS warehousing, Autonomous Guided Vehicles, and integrated systems.
Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
CQE, or CQA certification from the American Society for Quality (ASQ)
Computer Systems Quality (CSQA) experience
Previous facility or area start up experience.
Additional Information:
Ability to work 8-hour days - Monday through Friday (Day Shift).
Ability to work overtime as needed and be on-call as required.
Proven ability to work independently or as part of a Team to resolve an issue.
Applicant may work in various areas within the PAR, DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.
The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
Ability to travel up to 10% to 3PL Locations or Indianapolis, IN for meetings and coordination with global regulatory organizations required
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
WeAreLilly
