{"id":2560529,"url":"https://alion.io/job/mentor-technical-group-gxp-auditor-mentor-technical-group","title":"GxP Auditor - Mentor Technical Group","company":{"id":4419245,"name":"Mentor Technical Group","domain":"mentortg.com","url":"https://alion.io/company/mentortg","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Finance","role_family":"Finance","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":88000,"max_usd":168000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4389},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-14T20:30:26Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-19T03:31:01Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Mentor Technical Group (MTG) is seeking an experienced GxP Auditor to support pharmaceutical, biotechnology, medical device, and other regulated Life Sciences clients across the United States.\nThe GxP Auditor will plan, execute, document, and follow up on audits and compliance assessments to evaluate adherence to applicable regulatory requirements, industry standards, client procedures, and Quality Management Systems (QMS).\nThe role requires strong knowledge of GMP regulations, Quality Systems, audit methodologies, and regulatory expectations, as well as the ability to independently identify compliance gaps, assess risk, communicate findings, and provide practical recommendations for remediation.\nKey Responsibilities\nPlan, prepare, conduct, and document GxP audits and compliance assessments at client and supplier facilities.\nPerform audits of manufacturing operations, laboratories, warehouses, utilities, engineering systems, computerized systems, and other GxP-regulated activities, as applicable.\nConduct internal audits, supplier/vendor audits, third-party audits, mock regulatory inspections, and compliance gap assessments.\nEvaluate compliance with applicable FDA regulations, 21 CFR Parts 210 and 211, 21 CFR Part 11, and relevant ICH guidance and industry standards.\nReview Quality Management System elements including:\nDeviations and investigations\n\nCAPA\n\nChange Control\n\nDocument Control\n\nTraining\n\nData Integrity\n\nValidation and Qualification\n\nComputerized Systems\n\nSupplier Quality\n\nComplaints and Quality Events\n\nAnnual Product Reviews / Product Quality Reviews\n\nEvaluate the effectiveness and maturity of client Quality Systems and identify potential regulatory and compliance risks.\nConduct interviews with SMEs, Quality personnel, management, and operational staff during audits.\nReview procedures, records, protocols, reports, batch documentation, validation documentation, and other controlled records.\nClearly document audit observations and classify findings based on risk, regulatory impact, and established client procedures.\nPrepare clear, concise, and defensible audit reports.\nPresent audit findings to client management and relevant stakeholders during closing meetings.\nReview client responses and CAPA plans for adequacy and effectiveness.\nSupport FDA inspection readiness and remediation programs, including mock inspections and regulatory gap assessments.\nProvide compliance guidance and recommendations while maintaining auditor independence and objectivity.\nMaintain awareness of changes in FDA regulations, guidance documents, enforcement trends, and industry best practices.\nSupport MTG business development and technical teams by providing GxP auditing and regulatory compliance expertise when required.\nMinimum Qualifications\nBachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, Biology, or a related technical/scientific discipline.\nMinimum 5 years of experience in a GxP-regulated Life Sciences environment.\nMinimum 3 years of direct auditing, Quality Assurance, compliance, or regulatory experience.\nDemonstrated knowledge of cGMP requirements and FDA-regulated Quality Systems.\nExperience conducting or supporting internal, supplier, or regulatory compliance audits.\nStrong understanding of Quality Systems, risk management, investigations, CAPA, change control, and data integrity.\nStrong technical writing skills and experience preparing formal audit reports.\nExcellent verbal communication and interviewing skills.\nAbility to independently manage audit activities and interact effectively with client management and technical SMEs.\nAbility and willingness to travel throughout the United States based on project requirements.\nPreferred Qualifications\nLead Auditor certification or recognized auditor training.\n ASQ Certified Quality Auditor (CQA) or equivalent certification.\nExperience supporting FDA inspections, Warning Letter remediation, Consent Decree remediation, or major compliance improvement programs.\nKnowledge of ICH Q7, Q9, Q10, ISO 13485, 21 CFR Part 820, EU GMP, Annex 1, Annex 11, or other applicable international standards.\nExperience auditing pharmaceutical manufacturing, biotechnology, sterile manufacturing, laboratories, computerized systems, engineering, or validation activities.\nExperience with CSV/CSA, Data Integrity, ALCOA+, and 21 CFR Part 11.\nPrevious consulting experience within the Life Sciences industry.\nCore Competencies\nGxP Regulatory Compliance\nAudit Planning and Execution\nQuality Systems Assessment\nRisk-Based Decision Making\nRoot Cause and CAPA Evaluation\nData Integrity\nTechnical Documentation\nRegulatory Inspection Readiness\nClient Communication\nCritical Thinking and Problem Solving\nProfessional Judgment and Independence\nMentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.\n Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.","description_format":"text","description_chars":5449,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Science & Engineering","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-10-14T20:30:26Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":38,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/mentor-technical-group-gxp-auditor-mentor-technical-group","json_url":"https://alion.io/job/mentor-technical-group-gxp-auditor-mentor-technical-group.json","meta":{"generated_at":"2026-10-19T13:00:44Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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