Quality Assurance Specialist

San Diego, CA

Full Time

Mid Level

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

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Quality Assurance Specialist

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