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Quality Assurance Specialist

Full-time

Peregrine Team

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

Vacancy posted 6 days ago
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