Senior Quality Engineering Specialist
Prime Medicine
Senior Quality Engineering Specialist at a gene-editing biotech company provides operational support for GxP-regulated software, equipment, and vendor oversight. The role executes qualification activities, maintains compliance records, and conducts risk-based assessments of software vendors and suppliers.
Responsibilities
- Draft, execute, and review software assurance test scripts for GxP systems
- Conduct risk-based assessments of software vendors per FDA guidance
- Support quality oversight of computerized systems including AI-enabled tools
- Maintain accurate records and coordinate scheduled qualification and maintenance activities
- Evaluate equipment, material suppliers, and service providers for quality and reliability
Requirements
- Experience with GxP software systems and computerized system validation
- Knowledge of FDA guidance for software vendor assessment and risk evaluation
- Hands-on expertise in equipment qualification and preventive maintenance
- Ability to develop and execute test scripts based on specifications and requirements
- Strong understanding of regulatory compliance and inspection readiness protocols
Vacancy posted 29 days ago
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