Quality Assurance Careers – Cell Therapy & Integrated Biologics

Quality Assurance Careers – Cell Therapy & Integrated Biologics

Location: Portsmouth, NH – Positions are based at our Portsmouth, NH site. We offer multiple shift options depending on the role, including standard day shift (Monday–Friday, 8:00 AM–5:00 PM EST), second shift, and third shift opportunities. Third shift roles operate on a 12-hour rotating schedule (7:00 PM–7:00 AM), following a biweekly rotation of alternating workdays and days off.

About the Opportunity

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.

What You Will Do

Depending on role level and assignment, QA professionals may:

• 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

What We Are Looking For

We are hiring across multiple QA levels, but ideal candidates will have:

• 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
• Experience with any of the following is a plus:
  • 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.)

Who Thrives Here

Successful QA professionals in our organization are:

• Detail-oriented and quality-driven
• Comfortable making decisions in a regulated environment
• Strong communicators across technical and operational teams
• Passionate about continuous improvement and patient impact
• Able to balance compliance with operational execution

Why Join Us

• 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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.

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