QA Specialist V - Raw Materials

Job Title: QA Specialist V – Raw Materials

Location: Portsmouth, NH

The QA Specialist V - Raw Materials is responsible for providing Quality Assurance oversight of raw materials, consumables, single-use systems, supplier-provided services, and supplier quality systems supporting GMP manufacturing operations at the Portsmouth site.  The role ensures supplier qualification activities, incoming material controls, supplier quality agreements, supplier investigations, quality risk assessments, and material disposition activities are conducted in accordance with applicable regulatory requirements, corporate standards, and site procedures.

This role follows a 8-hour day shift schedule from 8:00 AM to 4:30PM Monday through Friday.

What you will get

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• Medical, dental, and vision insurance

• Opportunities to grow and develop your career

• A collaborative and supportive team environment

What you will do

• Function as a designated Portsmouth supplier quality point of contact (SPOC) supporting local and global supplier quality initiatives

• Serve as site Subject Matter Expert (SME) for supplier quality systems, quality agreements, supplier oversight, and supplier compliance requirements.

• Serve as Raw Materials Compliance and Supplier Quality SME during customer audits, regulatory inspections, supplier audits, and internal audits.

• Provide raw materials compliance and incoming material oversight.

• Support investigations, supplier quality events, deviations, and corrective action activities

• Support technology transfers, new product introductions, process improvements, supplier transitions, and strategic quality initiatives.

• Support implementation of global supplier quality standards and site quality objectives.

• Drive a culture of quality, compliance, continuous improvement, and inspection readiness.

• Collaborate with Manufacturing, Quality Control, Technical Services, Validation, Supply Chain, Procurement, Materials Management, Regulatory Affairs, and Global Supplier Quality teams to drive continuous improvement.

What we are looking for

• Experience in supplier quality, raw materials compliance, or Quality Assurance within a pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy environment

• Strong knowledge of GMP regulations and quality systems in a manufacturing setting

• Experience supporting supplier qualification, supplier oversight, and risk management activities

• Ability to lead investigations, assess quality risks, and make informed quality decisions

• Strong communication skills with the ability to collaborate across multiple departments and stakeholders

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or a related field, or equivalent experience.

• Experience with quality systems and electronic platforms such as TrackWise, LIMS, or similar applications is preferred

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.