About this role
QC Specialist III – Raw Materials (Cell Therapy)
Location: Portsmouth, NH.
This QC Specialist III is a key contributor to the raw material release process, coordinating the flow of materials from receipt through testing, data authorization, and final release. It offers the opportunity to lead cross-functional and external projects while ensuring compliance with global compendial and cGMP requirements.
What you will get:
Competitive salary and comprehensive benefits package
Opportunities for career development and advancement
Supportive and collaborative team environment
Access to cutting-edge technology and tools
Commitment to employee well-being and safety
Inclusive workplace culture
Recognition and reward for your contributions
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
Coordinate the end-to-end raw material release process, including receipt, sampling, testing, data authorization, and archival.
Support raw material sampling, testing decisions, sample distribution, and data management within LIMS, including template creation and review-driven corrections.
Prepare and maintain raw material documentation packets from receipt through release and long-term archival.
Function as project manager for externally tested raw materials, coordinating internal stakeholders and external laboratories through routine touchpoints.
Generate and manage blanket purchase orders for external testing, including invoice reconciliation in SAP.
Own and/or manage SOPs and work instructions related to raw material coordination activities.
Participate in and lead strategic projects to improve the health, efficiency, and robustness of raw material testing, including data trending and historical analysis.
What we are looking for:
Bachelor's or Associate's Degree preferably in Microbiology, Biochemistry, or related science discipline.
2-4 year’s of GMP industry experience; 2+ years experience supporting raw material testing, release, or quality activities in a cGMP-regulated environment.
Working knowledge of pharmacopeial requirements (USP, EP, JP) and their application to raw material testing and documentation.
Advanced proficiency in Microsoft Office applications, particularly Word and Excel
Experience with document management systems (DMS), document control, and change management practices
Strong technical writing, proofreading, and editing skills for protocols, reports, specifications, and methods
Familiarity with computerized management systems such as LIMS and SAP
Ability to interpret written and verbal instructions clearly, manage timelines, and lead projects across stakeholders
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.
Ready to shape the future of life sciences? Apply now.
About Lonza
Swiss contract development and manufacturing organization (CDMO) providing biologics, cell, and gene therapy production services.
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