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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Numbers & Facts
Location
San Diego, CA
Skills
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Communication Skillsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Documentationunmatched
External Auditunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Operationsunmatched
Manufacturing Requirementsunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Managementunmatched
Regulatory Complianceunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Systems Maintenanceunmatched
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