Quality Assurance Specialist III - Remote

Overview

The QA Specialist III will provide QA support for Quality Operations in a fast-paced pharmaceutical environment, focusing on QA activities and requiring diverse skill sets.

In Short

• Support reporting of Quality metrics
• Support quality risk management frameworks
• Perform batch record review
• Evaluate compliance of manufacturing records
• Maintain Continued Process Verification data
• Review Quality System documentation
• Evaluate document changes for compliance
• Support analysis of quality trends
• Conduct QA oversight activities
• Support training for employees

Requirements

• Bachelor’s degree in science or equivalent experience
• 7+ years of GxP experience
• Experience in a manufacturing setting
• Knowledge of quality risk assessment
• Extensive knowledge of GMP regulations
• Experience with Quality Assurance systems
• Strong technical writing skills
• Advanced software skills
• Effective communication skills
• Strong team player

Benefits

• 401(k) plan with employer match
• 12 weeks of paid parental leave
• Health plans (medical, dental, vision)
• Life insurance and disability
• Flexible time off
• Annual Winter Holiday shut down
• At least 11 paid holidays