Senior GMP & eQMS Quality Engineer CAPA & Audits

Hubot | Tri Pac, Inc. CDMO

  • South Bend, IN
  • 3 days ago
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    Skills

    • Change Controlunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • FDA (Food and Drug Administration)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Mentoringunmatched
    • Quality Engineeringunmatched
    • Root Cause Analysisunmatched
    • Safety Complianceunmatched
    • Standard Operating Procedures (SOP)unmatched

    Description

    Hubot, Inc. in Indiana is seeking a Senior Quality Engineer to uphold GMP standards, lead root-cause investigations, and steer eQMS modernization while ensuring batch safety, compliance, and audit readiness.You will review batch records, SOPs, and change controls, drive CAPAs, support audits with FDA/ISO frameworks, and mentor teams to sustain continuous improvement in a fast-growing environment. Candidates should have 7–9 years in GMP environments, hands-on eQMS experience, and a BS/BA in a#J-18808-Ljbffr

    Numbers & Facts

    LocationSouth Bend, IN

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