QA Specialist II-Raw Materials Compliance
Lonza Portsmouth, New Hampshire, United States
Pharmaceutical Manufacturing · 10,001+ employees
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About the role
The QA Specialist II will perform quality release activities for raw materials and ensure compliance with cGMP and GDP standards. They will also partner with cross-functional teams to resolve material-related issues, support investigations, and drive continuous improvement in quality processes.
What they look for
Requirements
Candidates must hold a Bachelor's degree in science or engineering and possess at least 5 years of quality experience in a regulated industry. Strong knowledge of cGMP and GDP requirements, along with excellent documentation review and problem-solving skills, is essential.
Benefits
Full 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.
Ready to shape the future of life sciences? Apply now.
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