QA Specialist V - Raw Materials

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

Benefits offered by this job

Medical, dental, and vision insurance

Career development opportunities

Collaborative team environment

Job summary

Lonza in Portsmouth, NH is seeking a QA Specialist V – Raw Materials to oversee supplier quality, raw materials, and related systems in a GMP manufacturing environment. You will ensure supplier qualification, material disposition, and investigations align with regulatory standards while supporting site quality objectives.

The role emphasizes collaboration across Manufacturing, Quality, Regulatory Affairs, and Supply Chain, with a focus on continuous improvement and audits.

Qualifications

• Experience in supplier quality, raw materials compliance, or QA in pharma/biotech environment.
• Strong knowledge of GMP regulations and quality systems in manufacturing.
• Experience with supplier qualification, supplier oversight, and risk management.
• Ability to lead investigations and assess quality risks.
• Strong communication across departments and stakeholders.

Responsibilities

• Serve as supplier quality SPOC for Portsmouth and global initiatives.
• SME for supplier quality systems, agreements, oversight, and compliance.
• Act as Raw Materials Compliance SME during audits, inspections, and supplier audits.
• Provide raw materials compliance and incoming material oversight.
• Support investigations, deviations, and CAPA activities.
• Support technology transfers, process improvements, and supplier transitions.
• Drive implementation of global supplier quality standards and site quality objectives.
• Collaborate with Manufacturing, QC, Regulatory Affairs, and Global Supplier Quality teams.

Skills

Supplier quality

GMP knowledge

Quality systems

Investigations

Communication

Education

Bachelor's degree in Life Sciences/Engineering or related field

Tools

TrackWise

LIMS

Job description

United States, Portsmouth (New Hampshire)

\u003Cb\u003EJob Title: \u003C\/b\u003EQA Specialist V – Raw Materials

\u003Cb\u003ELocation: \u003C\/b\u003EPortsmouth, 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.

\u003Cb\u003EWhat you will get:\u003C\/b\u003E

• 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

\u003Cb\u003EWhat you will do:\u003C\/b\u003E

• 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.

\u003Cb\u003EWhat we are looking for:\u003C\/b\u003E

• 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

\u003Cb\u003EAbout Lonza\u003C\/b\u003E

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.

Reference: R80153

You will feel at home at Lonza if you:

• 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, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

\u003Cb\u003EWe are the makers of the medicines of tomorrow.\u003C\/b\u003E