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
