Quality Assurance Specialist (Biotech)

Location: On-site in Framingham, MA

Salary: $106,000 - $137,000 per year

Company

hirify.global is a clinical-stage biotechnology company dedicated to transforming cancer treatment through the development of novel oncolytic immunotherapies.

What you will do

• Support day-to-day Quality Assurance operations to maintain the Quality Management System (QMS) in compliance with FDA and MHRA standards.
• Perform batch release for GMP lots and manage associated quality records.
• Oversee change control, deviation, and CAPA systems, including conducting root cause analysis investigations.
• Review and approve SOPs, validation protocols, production records, and testing documentation.
• Participate in vendor qualification processes and author quality technical agreements.
• Collaborate cross-functionally with Quality Control, Regulatory, and Clinical teams to ensure commercial readiness.

Requirements

• 3-5 years of quality experience within the biotech or pharmaceutical industry.
• Formal degree (Associates degree with relevant experience may be considered).
• Strong understanding of GMP compliance and regulatory standards.
• Excellent attention to detail and methodical approach to documentation.
• Proficiency in Microsoft Office.
• Must be able to work on-site in Framingham, MA.

Culture & Benefits

• Competitive base pay with annual performance incentive bonuses.
• Equity participation through new hire and ongoing performance-based grants.
• Comprehensive benefits including medical, dental, and vision insurance.
• 401k retirement plan with company match.
• Flexible time off and paid holidays, including a year-end shutdown.