{"schemaVersion":"jobsearcher.job.v1","id":"fa9102607db6508dedbaa4a8","url":"https://jobsearcher.com/jobs/fa9102607db6508dedbaa4a8","canonicalUrl":"https://jobsearcher.com/jobs/fa9102607db6508dedbaa4a8","title":"Documentation Coordinator","description":"Document Coordinator\nThis role is 100% ONSITE\nDevens, MA\nWork Schedule: Mon - Fri\nResponsibilities:\n1. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.\n2. Manages the document change control process, coordinating cross functional reviews, approvals and effective dates in alignment with requirements (cGMP and BMS) and customer needs\n3. Serves as a subject matter expert for the electronic document management system.\n4. May assist in user training on the electronic document management system.\n5. Provides Records Management support during in regulatory agency inspections and corporate audits.\nEducation and skills\nMinimum HS diploma with related experience required. B.S. degree (in Science, Engineering, Biochemistry) is preferred.\nA minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.\nStrong teamwork and communication skills and the ability to follow written and verbal instructions.\nKnowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.\nFamiliarity with US and EU cGMP regulations and guidance is required.\nWorking knowledge of common computer systems such as MS-Word and Excel is required.\nExperience with electronic document management systems, is preferred.\nJob Types: Contract, Full-time\nPay: $35.00 - $37.00 per hour\nSchedule:\n8 hour shift\nExperience:\nDocument management systems: 2 years (Required)\nregulated environment: 2 years (Required)\nUS and EU cGMP regulations: 1 year (Required)\nWork Location: In person","company":"Codetru","rawCompany":"codetru","city":"Devens","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-06T11:27:36.862Z","occupations":[{"code":"15-1299.03","title":"Document Management Specialists","slug":"document-management-specialists"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"561410","title":"Document Preparation Services","slug":"document-preparation-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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":"Documentation Coordinator","description":"Document Coordinator\nThis role is 100% ONSITE\nDevens, MA\nWork Schedule: Mon - Fri\nResponsibilities:\n1. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.\n2. Manages the document change control process, coordinating cross functional reviews, approvals and effective dates in alignment with requirements (cGMP and BMS) and customer needs\n3. Serves as a subject matter expert for the electronic document management system.\n4. May assist in user training on the electronic document management system.\n5. Provides Records Management support during in regulatory agency inspections and corporate audits.\nEducation and skills\nMinimum HS diploma with related experience required. B.S. degree (in Science, Engineering, Biochemistry) is preferred.\nA minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality.\nStrong teamwork and communication skills and the ability to follow written and verbal instructions.\nKnowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.\nFamiliarity with US and EU cGMP regulations and guidance is required.\nWorking knowledge of common computer systems such as MS-Word and Excel is required.\nExperience with electronic document management systems, is preferred.\nJob Types: Contract, Full-time\nPay: $35.00 - $37.00 per hour\nSchedule:\n8 hour shift\nExperience:\nDocument management systems: 2 years (Required)\nregulated environment: 2 years (Required)\nUS and EU cGMP regulations: 1 year (Required)\nWork Location: In person","datePosted":"2026-08-06T11:27:36.862Z","dateModified":"2026-08-06T11:27:36.862Z","hiringOrganization":{"@type":"Organization","name":"Codetru","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Devens","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fa9102607db6508dedbaa4a8"},"url":"https://jobsearcher.com/jobs/fa9102607db6508dedbaa4a8"}}