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Senior Quality Control Engineer

Karwell Technologies
  • Frankford, DE
  • Instant Apply
30+ days ago

Job Description

Roles & Responsibilities:
  • Lead implementation and integration activities for GMP QC systems.
  • Coordinate system configuration, data migration, deployment, and stakeholder engagement.
  • Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
  • Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
  • Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.
Required skills:
  • 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
  • Experience managing system integrations, data migration, and cross-functional project delivery.
  • Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities

Numbers & Facts

LocationFrankford, DE

Skills

  • Agile Programming Methodologiesunmatched
  • Biotech and Pharmaceuticalunmatched
  • Budgetingunmatched
  • Communication Skillsunmatched
  • Computer Systemsunmatched
  • Control Engineeringunmatched
  • Cross-Functionalunmatched
  • Data Migrationunmatched
  • Data Qualityunmatched
  • Documentationunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • GxPunmatched
  • Laboratory Information Management System (LIMS)unmatched
  • Laboratory Systemsunmatched
  • Maintain Complianceunmatched
  • Organizational Skillsunmatched
  • Process Validationunmatched
  • Project Executionunmatched
  • Project Trackingunmatched
  • Project/Program Coordinationunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Quality Engineeringunmatched
  • Regulationsunmatched
  • Reporting Skillsunmatched
  • Risk Analysisunmatched
  • Scientific Data Management System (SDMS)unmatched
  • Scrum Project Management and Software Developmentunmatched
  • Status Reportsunmatched
  • System Integration (SI)unmatched
  • System Validationunmatched
  • Systems Administration/Managementunmatched
  • Testingunmatched

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