Specialist II, Quality Assurance

JOB SUMMARY

Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices). 

The role is responsible for (1) QA lead for internal and external projects (2) independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements (3) executing Quality Management System requirements in support of commercial and developmental programs (4) ensuring the realization of industry best practices for GxP and (5) serving as quality approval proxy as required

This position is responsible for performing various functions as an owner, reviewer and/or approver. These functions include deviations, change controls, CAPAs, Complaints, Quality Risk Management validation and transfer protocols reports,...