{"schemaVersion":"jobsearcher.job.v1","id":"6604a318b85c16d37d0e6007","url":"https://jobsearcher.com/jobs/6604a318b85c16d37d0e6007","canonicalUrl":"https://jobsearcher.com/jobs/6604a318b85c16d37d0e6007","title":"Quality Specialist","description":"Duration & Type: 12 months Contract with a major pharmaceutical industry client\nLocation: Indianapolis, Indiana.\nThe position could be remote, with a need to travel to the site probably 5-10 days per month and the person would need to be in a surrounding state or greater mid-west area.\nResponsibilities:\nAssist in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation\nAssure compliance with SOPs upon implementation. Investigate and propose additional corrective actions as required.\nCommunicate with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.\nAssist in ensuring validation approaches are current to regulatory expectations and standards within the industry:\nWrite test cases to validate critical control points, user requirements, and functional designs. Execute test cases as needed.\nInteract with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.\nAssist in analyzing validation data to ensure acceptance criteria are met and in writing validation summaries. Prepare validation reports for distribution.\nEvaluate adequacy of corrective actions.\nParticipate in the evaluation of processes, systems, and individual center equipment needs and final approval process\nPrepare validation equipment for use at the Donor Center and for evaluation upon return.\nAssist in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.\nTrack and monitor process/system failures/events. Provide feedback to Donor Center management regarding requirements, results from data collected, and validation processes.\nMonitor customer complaints and nonconformance related to equipment failures.\nRequired:\nEducation: Bachelor’s degree\nStrong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.\nExcellent quantitative and analytical skills.\nExcellent oral and written communication skills. Strong critical thinking and problem-solving skills.\nAbility to identify errors and provide corrective action.\nAbility to work with others in a team environment.\nKnowledge of Microsoft Office applications and computer applications used in the Donor Centers.\nFor consideration, please send resume to career@infoquestgroup.com","company":"Infoquest Consulting Group","rawCompany":"infoquest consulting group","city":"Indianapolis","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-08-06T12:51:36.459Z","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":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Specialist","description":"Duration & Type: 12 months Contract with a major pharmaceutical industry client\nLocation: Indianapolis, Indiana.\nThe position could be remote, with a need to travel to the site probably 5-10 days per month and the person would need to be in a surrounding state or greater mid-west area.\nResponsibilities:\nAssist in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation\nAssure compliance with SOPs upon implementation. Investigate and propose additional corrective actions as required.\nCommunicate with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.\nAssist in ensuring validation approaches are current to regulatory expectations and standards within the industry:\nWrite test cases to validate critical control points, user requirements, and functional designs. Execute test cases as needed.\nInteract with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.\nAssist in analyzing validation data to ensure acceptance criteria are met and in writing validation summaries. Prepare validation reports for distribution.\nEvaluate adequacy of corrective actions.\nParticipate in the evaluation of processes, systems, and individual center equipment needs and final approval process\nPrepare validation equipment for use at the Donor Center and for evaluation upon return.\nAssist in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.\nTrack and monitor process/system failures/events. Provide feedback to Donor Center management regarding requirements, results from data collected, and validation processes.\nMonitor customer complaints and nonconformance related to equipment failures.\nRequired:\nEducation: Bachelor’s degree\nStrong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.\nExcellent quantitative and analytical skills.\nExcellent oral and written communication skills. Strong critical thinking and problem-solving skills.\nAbility to identify errors and provide corrective action.\nAbility to work with others in a team environment.\nKnowledge of Microsoft Office applications and computer applications used in the Donor Centers.\nFor consideration, please send resume to career@infoquestgroup.com","datePosted":"2026-08-06T12:51:36.459Z","dateModified":"2026-08-06T12:51:36.459Z","hiringOrganization":{"@type":"Organization","name":"Infoquest Consulting Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Indianapolis","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6604a318b85c16d37d0e6007"},"url":"https://jobsearcher.com/jobs/6604a318b85c16d37d0e6007"}}