What are the responsibilities and job description for the QC Specialist III - Raw Materials position at Lonza?
United States, Portsmouth (New Hampshire)
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
What You Will Do
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.
Reference: R72392
Apply
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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
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.
- 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
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.
Reference: R72392
Apply
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R75396