{"id":3878,"date":"2026-08-06T16:08:40","date_gmt":"2026-08-06T16:08:40","guid":{"rendered":"https:\/\/jobs.medasource.com\/jobs\/job\/a1wcv000000toixeaq-gmp-compliance-investigator-durham-north-carolina\/"},"modified":"2026-08-06T16:08:42","modified_gmt":"2026-08-06T16:08:42","slug":"a1wcv000000toixeaq-gmp-compliance-investigator-durham-north-carolina","status":"publish","type":"job_listing","link":"https:\/\/jobs.medasource.com\/jobs\/job\/a1wcv000000toixeaq-gmp-compliance-investigator-durham-north-carolina\/","title":{"rendered":"GMP Compliance Investigator"},"content":{"rendered":"<h4>\n<h1>GMP Compliance Investigator \u2013 Equipment &#038; Facilities<\/h1>\n<h2>Overview<\/h2>\n<p>Our client is seeking a <strong>GMP Compliance Investigator \u2013 Equipment &#038; Facilities<\/strong> to support a GMP manufacturing laboratory focused on advanced cellular therapies. This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering closely with Manufacturing and Quality teams.<\/p>\n<p>This is a highly collaborative role for someone with strong GMP quality experience, exceptional technical writing skills, and the ability to manage complex investigations from initiation through closure.<\/p>\n<p><\/p>\n<h2>Responsibilities<\/h2>\n<ul>\n<li>Develop, revise, and maintain Standard Operating Procedures (SOPs) to ensure compliance with FDA and applicable regulatory requirements.<\/li>\n<li>Author and manage change controls related to SOP updates and manufacturing process improvements.<\/li>\n<li>Edit batch records and manufacturing documentation as needed.<\/li>\n<li>Initiate, investigate, author, and close deviations, CAPAs, investigations, and quality memos.<\/li>\n<li>Partner with Manufacturing and Quality teams to investigate manufacturing events and drive timely closure of quality records.<\/li>\n<li>Serve as the primary author for equipment and facility-related deviation investigations.<\/li>\n<li>Attend meetings with equipment vendors and internal stakeholders to gather information supporting investigations.<\/li>\n<li>Author validation documentation, including IQ, OQ, and PQ protocols, equipment assessments, and validation reports.<\/li>\n<li>Manage deviation, CAPA, and change control timelines to support on-time batch release.<\/li>\n<li>Perform failure mode analysis and root cause investigations.<\/li>\n<li>Support batch release activities from a compliance perspective.<\/li>\n<li>Ensure compliance with FDA regulations and applicable accreditation standards.<\/li>\n<li>Train and educate personnel on updated procedures, SOPs, quality systems, and compliance requirements.<\/li>\n<li>Assist during FDA, accreditation, sponsor, and regulatory inspections, including responses to audit observations.<\/li>\n<li>Monitor Quality Agreements to ensure sponsor notification requirements are met.<\/li>\n<li>Participate in continuous improvement initiatives to optimize quality systems and documentation processes.<\/li>\n<\/ul>\n<h2>Preferred Qualifications<\/h2>\n<ul>\n<li>Experience working in a Quality Assurance or GMP Compliance function within an FDA-regulated manufacturing environment.<\/li>\n<li>Experience supporting deviations, investigations, CAPAs, and change controls.<\/li>\n<li>Strong technical writing skills with experience authoring investigation reports and SOPs.<\/li>\n<li>Experience participating in FDA inspections, regulatory audits, and sponsor audits.<\/li>\n<li>Experience with electronic Quality Management Systems (QMS).<\/li>\n<li>Project management experience.<\/li>\n<li>Strong analytical and root cause investigation skills.<\/li>\n<li>Excellent written and verbal communication skills.<\/li>\n<li>Strong organizational skills with exceptional attention to detail.<\/li>\n<li>Ability to work independently while collaborating effectively across cross-functional teams.<\/li>\n<\/ul>\n<h2>Minimum Qualifications<\/h2>\n<p>Ed<strong>ucation<\/strong><\/p>\n<p><\/p>\n<ul>\n<li>Bachelor&#8217;s degree in Biology, Life Sciences, or a related scientific discipline.<\/li>\n<\/ul>\n<p>E<strong>xperience<\/strong><\/p>\n<p><\/p>\n<ul>\n<li>Minimum of <strong>6 years of Quality Assurance, Quality Systems, or GMP Compliance experience<\/strong> within a regulated manufacturing environment.<\/li>\n<li>A Master&#8217;s degree in a related field may substitute for two years of experience.<\/li>\n<\/ul>\n<p><\/p>\n<\/h4>\n","protected":false},"author":0,"featured_media":774,"template":"","meta":{"inline_featured_image":false,"_promoted":"","_job_location":"Durham, North Carolina","_application":"applications@staffingfuture.com","_company_name":"Medasource","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-types":[15],"class_list":["post-3878","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job-type-contract"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>GMP Compliance Investigator, Durham North Carolina<\/title>\n<meta name=\"description\" content=\"GMP Compliance Investigator, Durham North Carolina - - Search the latest jobs from Medasource. 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