QC Associate

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.The QC Associate is primarily responsible for assessing, establishing, and supporting quality systems within the Indianapolis Device Manufacturing (IDM) QC organization per applicable Lilly Quality Standards (LQS) and Global Quality Standards (GQS). This role provides daily quality control support, and guidance for the IDM QC Laboratory involving laboratory operations, testing practices, analytical equipment, and test method development impacting the Device Quality Control Laboratory.Responsibilities:Provide Quality Control technical support for the IDM QC laboratory related to device testing for commercial and development product (e.g., design verification, process validation, stability, and batch release testing).Support Event Management through roles of originator, executor, and investigator of quality observations/deviations and analytical investigations impacting the QC laboratory using root cause analysis.Support Change Management through roles of originator and executor, primarily completing impact analysis tasks and implementation steps.Serve as author, periodic reviewer, and/or subject matter expert (SME) for applicable IDM QC laboratory procedures, processes, and equipment, including training of laboratory personnel.Timely review and approval of GMP laboratory data and documentation: protocols, methods, technical reports, procedures, sampling plans, and rework/retest/resample instructions.Perform comprehensive technical review of lot release testing data generated by the IDM QC lab.Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory.Build and maintain working relationships with DDCS, PRD, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product.Participate in new product design and pre-launch preparation projects to support device specification and test method development, laboratory equipment validation, and device testing.Participate in departmental process improvement activities (continuous improvement).Participate in regulatory agency and internal inspections.Play a key role in the harmonization of global methods and support of local and global lab issues.Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly's and the industry's application.Basic Requirements:Bachelor's degree in STEM disciplineMinimum of 1 year of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL).Additional Preferences:Experience writing requirements documents (e.g., procedures) and developing training materialsAbility to mentor and train others – share learningExcellent teamwork and interpersonal skillsStrong critical thinking and problem solving skills with an ability to apply rationaleSelf-management / motivated and ability to multi-taskStrong verbal and written communication skills in EnglishComputer literate in Teams/Sharepoint, Windows, and Microsoft applications (Outlook, Excel, Word)Experience with parenteral products, dry products, or devicesExperience with analytical lab equipment (e.g., Zwick, CADI, MicroVu) and LIMS systems (e.g., Darwin, SmartLab, LabVantage)Previous experience with method developmentExperience with documentation and event management systems (e.g., Veeva/Quality Docs) especially related to analytical investigationsDemonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems, especially related to lab systems and data integrityAdditional Information:The position is day shift on site Monday-Friday. Occasional after-hours and holiday coverage may be required. The position supports limited (1-2 days per month) work from home.Limited travel may be required for OUS and domestic travel (