Quality Assurance Specialist

San Diego, CA Open
Peregrine Team is looking for Quality Assurance Specialist in San Diego, CA. This local job opportunity with ID 3662816704 is live since 2026-05-04 14:28:34.

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
  • 3-5+ 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

Required Skills