QA Representative

4 weeks ago

Indianapolis, United States Eli Lilly Full time

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.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.Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) are responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. The QA Representative - Contract Manufacturing provides oversight and support to contract manufacturing operations of medical devices and combination products. The primary responsibility is to oversee the quality of the components, sub-assemblies and finished devices manufactured at the Contract Manufacturers (CM) and supplied to Internal Lilly sites. The Quality Assurance Representative provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation.Responsibilities:Ensure that components, sub-assemblies and finished devices has been manufactured and released in compliance with cGMPsEvaluate if products manufactured at the CM meet requirements for batch releasePerform IDM Batch Release process as requested by managementReview/approve GMP documents for CMs process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures and validation packagesEnsure that Root Cause Investigations (RCIs) are complete, corrective or preventive actions are taken, and effectiveness checks are appropriate to address quality related issues at IDM and CMsProvide data (inputs) for management review, monthly metrics, quarterly business reviews, site compliance reporting, and post-launch risk management reportingParticipate in Failure Modes and Effects Analysis (FMEA)Initiate and support continuous improvement projectsAssist with internal audits and supplier audits and maintain supplier management requirementsSupport molding and non-molded part validation at CMsSupport design verification activitiesManage CM Quality Agreements and Quality Plans; ensure the expectations are monitored and met at the CMParticipate on joint process teamsMaintain knowledge and application of CM QMS to enable quicker, risk-based decisions relative to product qualityCoordinate process and design changes with assembly sitesVerify effectiveness activitiesBasic Requirements:Minimum of 5 years industry related experience which may include Quality, Technical Services, LRL Product Development, and/or Manufacturing of medical devicesBachelor's Degree in engineering or science related fieldsAdditional Skills/Preferences:Experience working with contract manufacturers and suppliers to partner and influence the quality mindsetKnowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA)Knowledge of Quality System elements and their application in a manufacturing environmentExperience with plastic molding/assembly operationsExperience with Outlook, Microsoft applications, Trackwise, Veeva, SAP, Darwin, and Master ControlEffective communication, interpersonal, and networking skillSelf-management skillsStrong attention to detailAbility to work as part of a matrixed teamProblem solving skillsMeets commitments and deadlinesAbility to multi-task and manage competing prioritiesStrong technical writing skills and proficiency in technical review of documentsStrong organizational, time management and planning skillsAdditional Information:Some US and OUS travel may be required (approximately 10%)Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.#WeAreLilly

  • Representative-IDAP QA Engineer

    1 month ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • QA Representative

    3 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Representative-IDAP QA Engineer

    2 weeks ago

    Indianapolis, United States Eli Lilly Full time

    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...

  • Representative-IDAP QA Engineer

    2 weeks ago

    Indianapolis, United States BioSpace, Inc. Full time

    Job Details 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...

  • Representative-IDAP QA Engineer

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Representative-IDAP QA Engineer

    4 days ago

    Indianapolis, United States BioSpace, Inc. Full time

    Job Details 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...

  • Representative-IDAP QA Engineer

    4 days ago

    Indianapolis, United States Eli Lilly Full time

    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...

  • Representative-IDAP QA Engineer

    1 day ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, the mission is to improve lives globally through groundbreaking discoveries in healthcare. Headquartered in Indianapolis, Indiana, Lilly is a leading healthcare company dedicated to developing life-changing medicines, advancing disease management, and supporting communities through philanthropy and volunteer work.Overview:The QA Engineer role at...

  • QA Device

    4 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Sr Associate

    2 weeks ago

    Indianapolis, United States Lilly Full time

    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...

  • Sr Associate

    2 weeks ago

    Indianapolis, United States BioSpace, Inc. Full time

    Job Details 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...

  • Sr Associate

    2 weeks ago

    Indianapolis, United States BioSpace Full time

    Job DetailsAt 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...

  • Sr Associate

    2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr Associate

    4 days ago

    Indianapolis, United States BioSpace, Inc. Full time

    Job Details 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...

  • Quality Assurance Complaints Representative

    3 days ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • QA Device

    1 month ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr Principal Associate

    2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr Principal Associate

    2 weeks ago

    Indianapolis, United States Lilly Full time

    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...

  • Sr Principal Associate

    2 weeks ago

    Indianapolis, United States BioSpace Full time

    Job DetailsAt 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...

  • Sr Principal Associate

    1 month ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...