Specialist, Quality Assurance

The Specialist, Quality Assurance performs varied work under general supervision, supporting quality assurance activities for manufacturing operations while following established protocols and work plans. The role requires attention to detail, sound judgment, and the ability to apply evaluation and problem-solving skills to ensure products are manufactured, tested, and released in compliance with FDA regulations, GXPs, and internal SOPs.

Requirements

• Master’s degree in a scientific discipline
• Experience in a GMP manufacturing environment
• Knowledge of FDA regulations, GXPs, and quality systems
• Strong written and verbal communication skills
• Ability to identify quality/compliance issues and escalate appropriately
• Strong organizational skills with ability to multitask and meet deadlines

Benefits

• Competitive medical benefits
• 401k
• 152 hours PTO
• 8 Paid Holidays