QA Specialist II-Raw Materials Compliance

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Career growth

Medical, dental, and vision insurance

Cross-functional exposure

Competitive compensation

Job summary

Lonza in Portsmouth, NH is seeking a QA Specialist II - Raw Materials Compliance to ensure quality, compliance, and availability of raw materials for life-changing therapies. You will partner with Quality, Supply Chain, Logistics, MSAT and other stakeholders to maintain uninterrupted operations while driving continuous improvement and inspection readiness.

The role emphasizes GDP compliance, material receipt controls, and quality documentation practices, with opportunities to train

Qualifications

• 5+ years of quality experience in a regulated industry.
• Strong knowledge of cGMP, GDP, and quality system requirements.
• Experience reviewing technical documentation, specifications, certificates, and quality records.
• Strong attention to detail, organizational skills, and documentation review capabilities.
• Proven problem-solving skills with the ability to identify quality risks and improvement opportunities.
• Effective communication, collaboration, and stakeholder management skills in a regulated environment.

Responsibilities

• Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results.
• Review supplier and manufacturer documentation to ensure accuracy, completeness, and compliance with approved requirements.
• Provide guidance on GDP compliance, material receipt and disposition activities, inventory controls, and quality documentation practices.
• Partner with QA, QC, Supply Chain, Logistics, and MSAT teams to resolve material-related issues and support timely material availability.
• Support investigations, deviations, and quality events by providing expertise in raw material quality and compliance requirements.
• Identify quality risks and process improvement opportunities while helping implement sustainable compliance solutions.
• Develop and deliver training while providing support and guidance on raw material quality requirements to cross-functional stakeholders

Skills

Quality assurance

Regulated industry experience

cGMP & GDP knowledge

Documentation review

Problem solving

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in science or engineering

Job description

QA Specialist II - Raw Materials Compliance

Location: Portsmouth, NH (On-site)

At Lonza, our greatest scientific solution is talented people working together to help improve lives around the world. As a QA Specialist II - Raw Materials Compliance, you will play a critical role in ensuring the quality, compliance, and availability of raw materials that support the manufacture of life-changing therapies.

This is an excellent opportunity for a quality professional who enjoys working cross-functionally, solving complex quality challenges, and influencing material compliance throughout the product lifecycle. You’ll partner with Quality, Supply Chain, Logistics, Manufacturing Science & Technology (MSAT), and other stakeholders to help maintain uninterrupted operations while driving continuous improvement and inspection readiness.

What you will get

• An agile career and dynamic working culture
• Opportunities to expand your expertise in quality systems and raw material compliance
• Exposure to cross-functional teams across Quality, Supply Chain, Logistics, and Manufacturing
• A collaborative and quality-focused work environment
• Compensation programs that recognize high performance
• Medical, dental, and vision insurance
• Opportunities to grow and develop your career

What you will do

• Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results
• Review supplier and manufacturer documentation to ensure accuracy, completeness, and compliance with approved requirements
• Provide guidance on GDP compliance, material receipt and disposition activities, inventory controls, and quality documentation practices
• Partner with QA, QC, Supply Chain, Logistics, and MSAT teams to resolve material-related issues and support timely material availability
• Support investigations, deviations, and quality events by providing expertise in raw material quality and compliance requirements
• Identify quality risks and process improvement opportunities while helping implement sustainable compliance solutions
• Develop and deliver training while providing support and guidance on raw material quality requirements to cross-functional stakeholders

What we are looking for

• Bachelor’s degree required; science or engineering background preferred
• Minimum 5 years of quality experience in a regulated industry
• Strong knowledge of cGMP, GDP, and quality system requirements
• Experience reviewing technical documentation, specifications, certificates, and quality records
• Strong attention to detail, organizational skills, and documentation review capabilities
• Proven problem-solving skills with the ability to identify quality risks and improvement opportunities
• Effective communication, collaboration, and stakeholder management skills in a regulated environment

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.