Quality Analyst

Job Title: Quality Systems Analyst |
Location: Boston, MA 02215 |
Duration: 12 Months Contract |
Shift: Monday-Friday (8:00 AM to 5:00 PM) – 40 Hours/Week

As a Quality Assurance Associate who will report to the Sr. Director of Quality Assurance Operations, you will be responsible, in part, for assisting with the continued quality oversight of GMP production and testing of clinical trial materials at contract development and manufacturing organizations (CDMOs) and contract testing labs (CTLs). In addition, you will be responsible for reviewing regulatory submissions and source data verification.

The individual will be a collaborative, quality professional with biotech GMP compliance experience, and exceptional communication skills to support a pipeline of gene editing products. This role will be responsible for document review as well as assisting with the maintenance of phase-appropriate quality systems, including GxP compliance, document control, validation, and quality control. This role is based at Verve's Boston headquarters.

• Assist in quality oversight for external GMP production and testing activities for clinical stage products and materials
• Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed
• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations
• Perform review of regulatory submissions and source data verification and assist in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
• Other duties as assigned

• Bachelor’s degree (scientific discipline preferred) and 4+ years documented quality experience in GMP environment or pharmaceutical/biopharmaceutical industry
• Strong written and verbal skills
• Ability to communicate across various cross-functional teams
• Ability to work independently and drive pending actions to completion
• Experience in GXP document review
• Strong computer skills – Word, Excel, and other electronic quality systems

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Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.