Quality Assurance Specialist

Quality Assurance Specialist

Peregrine Team is hiring a Quality Assurance Specialist to support a growing biotech organization focused on developing and manufacturing innovative therapies. This role will play a key part in maintaining quality systems, supporting audits, and ensuring compliance with cGMP standards across manufacturing and operations.

Key Responsibilities

• Review and approve batch records, deviations, and change controls in accordance with cGMP guidelines
• Support internal and external audits, including FDA inspections
• Maintain and update SOPs, quality documentation, and training records
• Partner cross-functionally with manufacturing, regulatory, and quality control teams
• Assist with CAPA investigations and root cause analysis

Qualifications

• Bachelor's degree in a scientific discipline or related field
• 35+ years of experience in a GMP-regulated environment (biotech/pharma preferred)
• Strong understanding of FDA regulations and quality systems
• Detail-oriented with strong documentation and communication skills