QA Specialist II-Raw Materials Compliance

Lonza•Portsmouth, NH

8d•Onsite

About The Position

Today, Lonza is a global leader in life sciences operating across five continents. While we work to deliver new therapies, we also support our employees in building rewarding careers. Join us and help shape the future of life sciences. The actual location of this job is on site in Portsmouth, NH. As a QA Specialist II – Raw Materials Compliance, you will support the operational compliance of the raw material lifecycle, including receipt, storage, handling, testing, dispensing, and disposition. You will also assist with final product storage and shipping logistics . This role is a developing Subject Matter Expert (SME) in cGMP documentation review and approval for raw materials, working closely with Supply Chain, Quality Control, and Manufacturing teams. 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. 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 thei r 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

Associate’s degree in life sciences ; equivalent experience considered.
0–4 years of experience in Quality Assurance or GMP environments.
Knowledge of GMP regulations and raw material compliance preferred.
Familiarity with SAP, TrackWise , and Microsoft Office Suite preferred.
Strong communication skills and ability to manage changing priorities.
Attention to detail and ability to work independently and in teams.
Business-fluent English

Responsibilities

Perform SAP transactions and other quality functions to support raw material lifecycle.
Provide on-the-floor support for raw material requests, including inspection and labeling.
Review material documents for disposition to ensure timely release.
Review and approve SOPs, work instructions, and validation documents in DMS.
Review and approve records in QMS (e.g., investigations, change controls, CAPAs).
Collaborate with Supply Chain, Quality Control, and Manufacturing for raw material support.
Participate in projects and routine meetings with minimal guidance.