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Senior Manager of Quality Investigations

Senior Manager of Quality Investigations

Germer International - Pharmaceutical RecruitingBlue Bell, PA, US
2 days ago
Job type
  • Full-time
Job description

Our client is seeking a Senior Manager / Associate Director of Investigations to lead deviation investigations and ensure timely, thorough, and compliant documentation of all quality related events.

  • Please note : Due to the confidentiality of the role the position is not in Blue Bell PA, located in MidWest

Responsibilities :

  • Assess and document product impact within the investigation
  • Conduct thorough root cause analysis and document within the investigation including causal factors identified and any root causes determined
  • Initiate appropriate corrective actions (CAPAs)
  • Position requires technical writing capabilities to create clear, concise investigations with appropriate details
  • Own CAPAs and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
  • Knowledge of TrackWise or Master Control databases is preferred.
  • Additional responsibilities may include cross-training as a Quality Contact to close investigations from other investigators and to close other reports in multiple quality systems.
  • Other duties may be assigned
  • Education and / or Experience :

  • Bachelor's Degree in Science, Chemistry, or Biology.
  • 8+ years of experience in quality assurance in the pharmaceutical industry
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    Senior Manager Quality • Blue Bell, PA, US

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