Quality Associate, QA Operations
$95,500–$117,000 year
HybridBedford, Massachusetts, United States
Job Summary
Support QA Operations CDMO point person to ensure CDMO adherence to Good Manufacturing Practices (GMP), applicable regulations, and Obsidian Therapeutics policies. Serve as a point of coordination for QA support across manufacturing operations by partnering with CMC, QA Operations, and Supply Chain/materials management teams to review documentation, resolve quality-related questions, and support timely execution of GMP activities. Review batch data (e.g., batch records, deviations, in-process data, EM data, QC release testing) to support product disposition decisions and maintain internal document repositories for audit readiness. Provide timely QA support for change controls, GMP investigations, associated CAPAs, and effectiveness checks, while participating in IND preparedness and inspection readiness activities. This hybrid role in Bedford, MA involves 10–20% travel and supports Obsidian's lead OBX-115 TIL therapy program.
Required Qualifications
- Bachelor's degree in biology, chemistry, engineering, life sciences or a related field
- 2+ years of relevant work experience
- M.S. degree
- 1+ years of relevant work experience
- Work experience in QA, QC, or Manufacturing
- Experience supporting lot disposition activities by reviewing batch data
- Experience supporting event investigations, Root Cause Analysis
- Understanding of cGMP's and associated CMC regulatory considerations
- Knowledge of cGMP, SOPs, and quality system processes
- Planning, coordination, and time management skills
- Excellent oral, written, and visual communication skills
- Ability to build and maintain productive relationships at all levels within and across internal teams, and with external partners
- Collaborative and accountable
- Self-motivated
- Flexible
- Curious and humble
- Tenacious and resilient
- Estimated travel: 10–20%
Desired Qualifications
- Work experience in QA, QC, or Manufacturing preferred
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