{"id":3296575,"url":"https://alion.io/job/ascential-test-measurement-systems-calibration-coordinator","title":"Calibration Coordinator","company":{"id":2056483,"name":"Ascential Test & Measurement Systems","domain":"ascentialtech.com","url":"https://alion.io/company/ascentialtech","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":{"grade":"B","score":75,"open_postings":7,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":40,"computed_at":"2026-11-02T06:13:15Z"}},"role":"Administrative","role_family":"Administrative","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ham Lake, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":44000,"max_usd":96000,"period":"year","method":"role_country_seniority_unknown","sample_n":11684},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"ICH Guidelines","optional":false},{"name":"ISO 13485","optional":false},{"name":"IVDR","optional":false}],"status":"live","first_seen_at":"2026-10-26T20:06:35Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-03T01:00:30Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"SUMMARY\nThe Calibration Coordinator is responsible for administering and maintaining the calibration program that ensures compliance with U.S. FDA regulations (21 CFR Parts 210/211 and 21 CFR Part 820) as well as international regulatory requirements and industry standards. This role supports product quality, data integrity, and inspection readiness across multiple regulatory jurisdictions, ensuring all instruments and systems are calibrated, documented, and controlled in accordance with global GMP and quality system expectations.\nESSENTIAL DUTIES AND RESPONSIBILITIES\nProgram Management\nCoordinate and manage the calibration program for manufacturing, laboratory, and facility equipment.\nMaintain calibration schedules aligned with regulatory requirements and risk-based methodologies.\nTrack and report key performance indicators (KPIs) (e.g., completion rates, overdue calibrations, OOT trends).\nRegulatory Compliance & Global Standards\nEnsure compliance with applicable regulations and standards, including but not limited to:\nU.S. FDA\n21 CFR Part 210/211 (cGMP - Pharmaceuticals)\n21 CFR Part 820 (Quality System Regulation - Medical Devices)\nEuropean Union\nEU GMP (EudraLex Volume 4)\nMedical Device Regulation (EU MDR 2017/745) and IVDR (as applicable)\nInternational Standards\nISO 13485 - Medical Device Quality Management Systems\nISO 9001 - Quality Management Systems\nISO/IEC 17025 - Calibration and Testing Laboratory Competence\nICH GuidelinesICH Q7, Q8, Q9, Q10 (Quality Risk Management, Pharmaceutical Quality Systems)\n\nOther Regulatory Bodies (as applicable)MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc.\n\nEnsure alignment with data integrity guidance (FDA, MHRA, PIC/S).\nMaintain continuous inspection readiness for global regulatory inspections and customer audits.\nDocumentation & Data Integrity\nMaintain calibration records, certificates, and traceability per ALCOA+ principles.\nEnsure calibration standards are traceable to NIST, SI units, or equivalent international standards.\nManage calibration data within CMMS and/or validated systems in compliance with:\n21 CFR Part 11 (Electronic Records/Electronic Signatures)\nAnnex 11 (EU computerized systems)\nReview calibration documentation for technical accuracy and regulatory compliance.\nOut-of-Tolerance (OOT) Investigations & Quality Systems\nLead or support investigations for calibration failures and out-of-tolerance conditions.\nConduct product impact assessments using risk-based methodologies (ICH Q9).\nCollaborate on CAPA activities to ensure effective root cause resolution and compliance.\nSupport deviation, change control, and nonconformance processes.\nVendor & Laboratory Management\nCoordinate external calibration service providers and laboratories.\nEnsure vendors are qualified per:\nISO/IEC 17025 accreditation\nInternal supplier quality requirements\nReview vendor documentation and audit performance where required.\nCross-Functional Collaboration\nPartner with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs teams.\nSupport equipment qualification (IQ/OQ/PQ) and lifecycle management.\nProvide calibration input into risk assessments, URS, and validation protocols.\nContinuous Improvement & Global Harmonization\nDrive improvements in calibration processes using Lean, Six Sigma, or operational excellence tools.\nImplement digital solutions and system upgrades (e.g., CMMS, calibration management software).\nEXPECTATIONS\nPerform duties following NACS, Inc. quality and safety standards\nParticipate in team building, training, and department communications\nUnderstand and follow all attendance related policies\nMaintain a high level of personal and professional integrity\nPerform additional job responsibilities as assigned\nQUALIFICATIONS\nHigh School Diploma or AA Degree at minimum with applicable work experience\nBachelor’s degree in Engineering, Life Sciences, Metrology, or related technical discipline preferred\n3-7+ years of calibration, metrology, or maintenance experience in a regulated pharmaceutical, biotech, or medical device environment\nDirect experience supporting global regulatory frameworks and audits\nStrong knowledge of cGMP and global GMP frameworks (FDA, EU, WHO)\nStrong knowledge of calibration principles and metrology best practices\nStrong knowledge of ISO/IEC 17025 laboratory requirements\nFamiliarity with CMMS systems (e.g., Master Control, ETQ, SAP PM)\nFamiliarity with data integrity principles and electronic systems compliance (Part 11, Annex 11)\nFamiliarity with working knowledge of risk management tools and statistical analysis\nStrong organizational and coordination skills across multiple stakeholders\nHigh attention to detail and compliance mindset\nAbility to communicate effectively in a cross-functional environment\nStrong analytical and problem-solving capabilities\nGlobal regulatory expertise\nInspection readiness and audit support\nData integrity and compliance\nRisk-based decision making\nCross-functional collaboration\nContinuous improvement mindset\nWORKING CONDITIONS\nOffice and GMP-regulated production/laboratory environments\nAbility to lift/carry/move up to 50 pounds.\nMay require standing for extended periods of time.\nExpected to wear all required PPE.\nSafely work independently and around others by following all required procedures.\n SUCCESS METRICS\nOn-time calibration completion rate\nReduction in overdue and OOT events\nAudit and inspection outcomes (FDA, EU, ISO)\nCAPA effectiveness and closure timelines\nData integrity compliance metrics\nVendor performance and compliance","description_format":"text","description_chars":5542,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Test & Measurement Instruments"],"lifecycle":[{"event":"open","at":"2026-10-26T22:04:31Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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