QA Specialist IV-Raw Materials

Lonza•Portsmouth, NH

10d•Onsite

About The Position

Join our Quality Assurance team and play a key role in ensuring compliance and operational support for the raw material lifecycle. Your expertise will help us maintain the highest standards in GMP and quality culture. 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. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits. 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.

Requirements

Bachelor’s degree in Life Sciences or related field (or equivalent experience).
5–10 years of experience in Quality Assurance within GMP environments.
Strong knowledge of GMP regulations and compliance requirements.
Experience with SAP, TrackWise, and document management systems.
Excellent communication and problem-solving skills.
Ability to work independently and lead complex issue resolution.

Nice To Haves

Biotechnology manufacturing experience preferred.

Responsibilities

Manage SAP transactions to support raw material lifecycle and ensure timely release for production.
Provide on-the-floor support for raw material requests and identify process improvements.
Review and approve material documents for disposition to support timely release.
Approve SOPs, work instructions, and validation documents relevant to raw material lifecycle.
Review and approve quality records such as investigations, CAPAs, and change controls.
Collaborate with Supply Chain, Quality Control, and Manufacturing to resolve issues.
Apply data integrity principles and maintain GMP compliance in all activities.