Quality Assurance Process Team Device Assembly and Packaging

Job ID: R-108638Company: LillyLocation: Concord, North Carolina, United States of AmericaJob Type: Full TimeCategory: Manufacturing/QualityPosted Date: 2026-07-21At 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 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.Responsibilities:The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards.This role will participate on the local process team for one of following manufacturing areas:Device Assembly Packaging Project Focus for DAPResponsibilities include:Active presence in operational areasProvide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.Provides guidance for leveling, resolving, reviewing and approving deviations and change controlsDemonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operationsLead and establish annual quality floor time planSupport resolution of batch documentation such as alarm response, exceptions, etcSupport asset qualification monitoring reviews and reportsRequired to respond to operational issues outside of core business hours / days.Attend and provide update on quality at daily process team meetingSupport the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staffResolve or escalate any compliance issues to Quality ManagementIdentify and implement continuous improvementsMeasure, maintain, and achieve quality metricsServe as positive role models for their Process Team peers and for the organization in generalBasic Requirements:Bachelors or equivalent degree in a scientific field4+ years’ experience in Quality pharmaceutical manufacturing requiredPrevious experience with C&Q / Verification and Validation oversight including automation and computer systems validationUse process knowledge and control strategy to make quality decisionsDemonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturingDemonstrated ability to communicate with cross-functional teams including good oral and written communication skillsAbility to work independently as a Quality SME with minimal supervisionProficiency with computer systems including SAP, Trackwise, MES etc.Responsible for maintaining a safe work environment, Ability to work 8 hour shifts onsite (not eligible for remote work)Ability to work overtime as requiredQualified 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 employment positions on the B or S paths or at levels M1-M2 or P1-P4.Additional Skills/Preferences:ASQ CertifiedCSQA experiencePrevious experience with device assembly or packaging, Previous experience with Manufacturing Execution Systems.Previous use of KNEAT – or other electronic validation softwarePrevious technical writing experience 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 () 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 (View email address on click.appcast.io), 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 - $169,400Full-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.#WeAreLillySkillsdevice assemblypackagingpharmaceutical manufacturingquality assuranceverification and validationchange controlprocess improvementcontinuous improvementsaptrackwisemeskneatus and eu regulationscross-functional team communicationmentoringtraining deliverytechnical writingasq certificationcsqa