Quality Assurance Specialist II

Expired

REVA Medical, LLC

$75,000 – $90,000 · Posted 1 month ago

San DiegoLast seen 1 month ago

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Summary

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections. The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

Quality Assurance Batch Release Calibration Capa Data Analysis Deviation Management Document Control Electronic Batch Record Ebr Excel Fda Submissions Gmp Ncmr Preventive Maintenance Process Validation Product Disposition Quality Event Investigation Regulatory Compliance Risk Assessment Root Cause Analysis Statistical Analysis