Quality Analyst, Quality Assurance

Role Overview

• Support Quality review of batch records, test results, and associated documentation to enable timely lot disposition.
• Assist in tracking manufacturing, testing, and release activities for clinical batches to support timely and compliant product delivery to patients.
• Coordinate with internal teams (Quality, Patient Operations, Program Management) and external partners, including CDMOs, to track batch status and communicate timelines and issues.
• Support Quality oversight activities to ensure compliance with applicable GMP regulations across internal operations and external partners.
• Assist with deviation, investigation, and CAPA tracking and follow-up.
• Contribute to tracking and reporting of key Quality and operational metrics.
• Assist in preparation of materials for Quality Management Reviews and internal reporting.
• Participate in inspection readiness activities and support audit preparation efforts.
• Provide general Quality support to ongoing manufacturing and development activities as needed.
• Provide support to ensure compliance of the Quality Management System and associated documentation.
• Support Internal Audit processes
• Travel required: 20%-40%

Requirements

• Bachelor’s degree in life sciences or related field.
• 1–3 years of experience in a Quality or GMP-regulated environment (biotech, pharma, or cell/gene therapy preferred).
• Familiarity with GMP principles and documentation practices.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective communication skills and ability to work cross-functionally.
• Experience supporting manufacturing or working with external partners (e.g., CDMOs) is a plus.
• Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.