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 investigationConduct thorough root cause analysis and document within the investigation including causal factors identified and any root causes determinedInitiate appropriate corrective actions (CAPAs)Position requires technical writing capabilities to create clear, concise investigations with appropriate detailsOwn 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 assignedEducation and / or Experience :
Bachelor's Degree in Science, Chemistry, or Biology.8+ years of experience in quality assurance in the pharmaceutical industry