Quality Assurance Careers – Cell Therapy & Integrated Biologics

Lonza • Portsmouth, NH

1d • Onsite

About The Position

Join our Quality Assurance team supporting the manufacture of life-changing cell therapy and biologic medicines. Our QA professionals play a critical role in ensuring product quality, regulatory compliance, and patient safety across GMP manufacturing operations. We are hiring across multiple QA levels—from entry-level batch review and documentation roles to senior operational, compliance, and investigation-focused positions. If you are passionate about quality, science, and making an impact in the life sciences industry, we want to meet you.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field (required for most roles)
• Experience in a GMP-regulated environment (pharma, biotech, biologics, or cell therapy preferred)
• Strong understanding of cGMP regulations and GDP principles
• Attention to detail and commitment to documentation accuracy and data integrity
• Strong communication and collaboration skills in cross-functional environments
• Ability to work in a fast-paced, regulated manufacturing environment

Nice To Haves

• Deviation investigations, CAPAs, or change control
• Batch record or lot release review
• On-the-floor QA support in manufacturing
• Quality systems (e.g., TrackWise, SAP, LIMS, DMS)
• Risk assessment tools (FMEA, fishbone, etc.)

Responsibilities

• Support GMP manufacturing operations for cell therapy and biologics products
• Perform batch record and documentation review to ensure accuracy, completeness, and compliance
• Support or lead deviation investigations, CAPAs, and change controls
• Provide on-the-floor QA oversight in manufacturing and operational areas
• Ensure compliance with cGMP, GDP, and data integrity standards
• Partner cross-functionally with Manufacturing, QC, Supply Chain, and other stakeholders
• Support product disposition and release activities
• Participate in inspection readiness, audits, and regulatory support activities
• Contribute to continuous improvement initiatives across quality systems and processes
• Apply risk-based thinking and problem-solving to support quality decisions

Benefits

• Work directly on advanced therapies that impact patient lives
• Be part of a globally connected Quality organization
• Gain exposure across cell therapy and biologics manufacturing
• Career growth across QA operations, systems, investigations, and leadership paths
• Competitive compensation and comprehensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level