QA Specialist IV-Raw Materials

QA specialist IV- Raw Materials  

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What you will get:

below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.

• Medical, dental and vision insurance.

• 401(k) matching plan.

• Life insurance, as well as short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

The QA Specialist IV – Raw Materials Compliance provides operational and compliance oversight across the raw material lifecycle, including material receipt, storage, handling, testing, dispensing, facility maintenance, area controls, and disposition. This role also supports quality activities related to final product storage, handling, and shipping logistics, while serving as a senior Subject Matter Expert (SME) for cGMP raw material documentation and quality processes.

• Serve as a Quality SME for the raw material lifecycle, ensuring compliance with cGMP requirements and internal quality standards.

• Perform and support SAP quality transactions related to raw material management to ensure the timely review, disposition, and release of materials for production.

• Provide on-the-floor quality support for raw material activities including inspection, assessment, labeling, and related operations.

• Independently review and approve raw material documentation to support timely material disposition and release.

• Review and approve controlled documents in the Document Management System (DMS) such as SOPs, work instructions, forms, specifications, and related documentation.

• Review and approve validation and qualification documentation, including protocols and summary reports for equipment, instrumentation, and applicable computer systems.

• Review and approve records in the Quality Management System (e.g., TrackWise) including deviations, investigations, change controls, and CAPAs.

• Collaborate cross-functionally with Supply Chain, Quality Control, and Manufacturing to support raw material operations and drive process improvements.

• Participate in interdepartmental projects, routine meetings, reporting activities, and continuous improvement initiatives while ensuring adherence to Data Integrity principles and Lonza quality policies.

What we are looking for:

• Bachelor’s degree in a scientific discipline required; equivalent combination of education and experience may be considered.

• 5–7 years of experience in Quality Assurance within a GMP-regulated environment.

• Strong working knowledge of GMP regulations and raw material compliance requirements.

• Experience with SAP, TrackWise, and Microsoft Office Suite preferred.

• Excellent written and verbal communication skills.

• Demonstrated ability to manage multiple priorities independently in a fast-paced environment.

• Strong attention to detail with the ability to collaborate cross-functionally and lead quality initiatives.

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.