Develop and maintain auditing & testing methods for packaging materials
Review and approve controlled documents including SOPs and Notifications
Coordinate initial response activity for deviations and out-of-specification events
Identify non conformances, recommend corrective action, and ensure follow-up
Manage and train non-exempt staff to meet cGMP and FDA standards
Assist with FDA inspections and ensure FDA readiness
Manage day-to-day workload and shifting priorities
Initiate, execute and oversee projects as required

Bachelor’s degree within a scientific discipline strongly preferred
Minimum of four (4) years of experience in a Quality role
Exceptional people management abilities
Previous experience in FDA regulated industry preferred
Good oral and written communication skills
Ability to interpret and apply formal regulations to product quality and processes
Familiarity with cGMP, quality assurance, release methods, auditing and/or risk assessment in an FDA regulated environment highly preferred
Knowledge of SAP preferred

QA Supervisor

Key skills