Compliance Specialist
Alten Calsoft LabsJob Description
📋 Description Review quality critical alarms and NRSR. Review J&Cs. Enter metrics into database. Initiate and investigate deviations for non-conformance. Containment assessment for deviations (off-hours). Provide off-hours support for batch record issuance. Back-up QA Manager. Other duties as assigned. 🎯 Requirements Bachelor's degree in a scientific field with 4-6 years in quality or cGMP. Master's degree in a scientific field with 2 years' experience in above. 2 years of experience in a quality role. Knowledge of external agency regulations (FDA, EMA, etc.) Strong computer, verbal and written communication skills. Experience in quality systems. Experience in leading cross-functional teams. Experience with TrackWise or equivalent system. Proficient in Microsoft Office.