{"schemaVersion":"jobsearcher.job.v1","id":"522a2fce53ebdcffd2e0f7bf","url":"https://jobsearcher.com/jobs/522a2fce53ebdcffd2e0f7bf","canonicalUrl":"https://jobsearcher.com/jobs/522a2fce53ebdcffd2e0f7bf","title":"Scientist-QA","description":"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.\r\nOrganization Overview: Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Scientist-QA assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities.\r\nResponsibilities The Scientist-QA for the Parenteral team provides oversight of the formulation or filling operations using isolator technology or visual inspection processes, assists and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, sterility assurance, commissioning, and qualification activities. In addition, cross-train in the visual inspection area to support collaborative quality and production team environment. The Scientist-QA position is essential for maintaining GMP compliance and providing support during preparation for pre-approval/general inspections by various regulatory agencies.\r\nSupport the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems.\r\nEffectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).\r\nActive on local process teams or indirect participation through project support activities\r\nLead, mentor, and coach operations and support personnel on quality matters.\r\nAbility to assess and triage deviations / observations that occur within Drug product formulation, filling and visual inspection processes.\r\nProvides guidance in operational areas to ensure robust Quality Systems and GMP compliance.\r\nSupport project and process improvement initiatives for Plant Process Teams as representative of the Quality function.\r\nAs applicable, approve commissioning qualification / validation documents for equipment to ensure compliance with quality standards.\r\nLiaison with Lilly support groups and external partners to resolve or provide advice on product related issues.\r\nParticipate in self-led inspections and provide support during internal / external regulatory inspections.\r\nResponsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.\r\nBasic Requirements Bachelor's in a Science or Engineering related.\r\nAdditional Skills/Preferences Minimum of 5 years of demonstrated experience in GMP facility.\r\nDemonstrate knowledge and understanding of aseptic manufacturing process, isolator technology, visual inspection, and Quality Systems.\r\nAbility to make technical decisions, provide guidance to the site and lead others.\r\nDemonstrated strong oral and written communication skills, interpersonal skills and ability to work as a team.\r\nRoot cause analysis/troubleshooting skills.\r\nDemonstrated attention to detail and ability to maintain quality systems.\r\nPrevious regulatory inspection readiness and inspection execution experience.\r\nProficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS), Deviation Management Systems (TrackWise), Change Management.\r\nCQA certification from the American Society for Quality (ASQ) or CSQA Experience.\r\nProficiency with computer systems including Microsoft office products.\r\nProven ability to work independently or as part of a team to resolve issues.\r\nAdditional Information Support for 24/7 manufacturing operation.\r\nFlexible working environment with the ability to work remotely 2 — 4 days a month.\r\nEEO and Benefits 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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\r\nEli Lilly\r\nJ-18808-Ljbffr","company":"Eli Lilly","rawCompany":"eli lilly","city":"Durham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-04-09T07:58:16.876Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"51-9061.00","title":"Inspectors, Testers, Sorters, Samplers, and Weighers","slug":"inspectors-testers-sorters-samplers-and-weighers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Scientist-QA","description":"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.\r\nOrganization Overview: Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Scientist-QA assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities.\r\nResponsibilities The Scientist-QA for the Parenteral team provides oversight of the formulation or filling operations using isolator technology or visual inspection processes, assists and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, sterility assurance, commissioning, and qualification activities. In addition, cross-train in the visual inspection area to support collaborative quality and production team environment. The Scientist-QA position is essential for maintaining GMP compliance and providing support during preparation for pre-approval/general inspections by various regulatory agencies.\r\nSupport the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems.\r\nEffectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).\r\nActive on local process teams or indirect participation through project support activities\r\nLead, mentor, and coach operations and support personnel on quality matters.\r\nAbility to assess and triage deviations / observations that occur within Drug product formulation, filling and visual inspection processes.\r\nProvides guidance in operational areas to ensure robust Quality Systems and GMP compliance.\r\nSupport project and process improvement initiatives for Plant Process Teams as representative of the Quality function.\r\nAs applicable, approve commissioning qualification / validation documents for equipment to ensure compliance with quality standards.\r\nLiaison with Lilly support groups and external partners to resolve or provide advice on product related issues.\r\nParticipate in self-led inspections and provide support during internal / external regulatory inspections.\r\nResponsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.\r\nBasic Requirements Bachelor's in a Science or Engineering related.\r\nAdditional Skills/Preferences Minimum of 5 years of demonstrated experience in GMP facility.\r\nDemonstrate knowledge and understanding of aseptic manufacturing process, isolator technology, visual inspection, and Quality Systems.\r\nAbility to make technical decisions, provide guidance to the site and lead others.\r\nDemonstrated strong oral and written communication skills, interpersonal skills and ability to work as a team.\r\nRoot cause analysis/troubleshooting skills.\r\nDemonstrated attention to detail and ability to maintain quality systems.\r\nPrevious regulatory inspection readiness and inspection execution experience.\r\nProficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS), Deviation Management Systems (TrackWise), Change Management.\r\nCQA certification from the American Society for Quality (ASQ) or CSQA Experience.\r\nProficiency with computer systems including Microsoft office products.\r\nProven ability to work independently or as part of a team to resolve issues.\r\nAdditional Information Support for 24/7 manufacturing operation.\r\nFlexible working environment with the ability to work remotely 2 — 4 days a month.\r\nEEO and Benefits 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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\r\nEli Lilly\r\nJ-18808-Ljbffr","datePosted":"2026-04-09T07:58:16.876Z","dateModified":"2026-04-09T07:58:16.876Z","hiringOrganization":{"@type":"Organization","name":"Eli Lilly","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"522a2fce53ebdcffd2e0f7bf"},"url":"https://jobsearcher.com/jobs/522a2fce53ebdcffd2e0f7bf"}}