QA Specialist V - Raw Materials

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Medical, dental, and vision insurance

Career growth opportunities

Collaborative team

Job summary

Lonza Group Ltd. in Portsmouth, NH is seeking an experienced QA Specialist V for Raw Materials. This role provides QA oversight of raw materials, supplier quality systems, and supplier agreements to ensure GMP compliance.

You will support investigations, deviations, and CAPA activities, collaborating with Manufacturing, Quality, Regulatory, and Procurement teams. The position requires knowledge of GMP and supplier quality processes, with a focus on continuous improvement and audit readiness.

Qualifications

• Experience in supplier quality, raw materials compliance, or QA in pharma/biotech.
• Strong knowledge of GMP regulations and quality systems in manufacturing.
• Experience supporting supplier qualification, oversight, and risk management.
• Ability to lead investigations and assess quality risks.
• Strong communication skills across departments and stakeholders.
• Bachelor's degree or equivalent experience in Life Sciences or related field.
• Experience with TrackWise or LIMS is preferred.

Responsibilities

• Provide QA oversight of raw materials, consumables, and supplier quality systems.
• Serve as SME for supplier quality, supplier agreements, and supplier audits.
• Support investigations, deviations, and corrective actions.
• Support technology transfers, new product introductions, and process improvements.
• Collaborate with cross-functional teams to drive quality improvements.

Skills

Experience in supplier quality

Quality Assurance

Strong communication skills

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related field

Tools

TrackWise

LIMS

Job description

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 4:30 PM 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.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong.

You will feel at home at Lonza if:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, we have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.