Job Summary

• The Senior Specialist will provide quality oversight on shop floor activities and ensure compliance with global current Good Manufacturing Practice standards.
• This role involves reviewing and approving critical documents including batch records, deviations, CAPAs, and change controls while supporting clinical and commercial operations.
• Candidates will benefit from a hybrid work environment, comprehensive health coverage, and flexible time off policies within a mission-driven oncology biotech team.

Matching Summary

Salary

Base: $82,236 - $99,650 annually; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellness programs

Skills & Requirements

Key Requirements

• BS/MS degree in science related field
• Minimum 5 years experience in QA or compliance roles
• Experience in GMP aseptic manufacturing environment preferred
• Knowledge of US, EU, and rest-of-world cGMP regulations

Work Rights