QA Specialist V - Raw Materials & Supplier Quality Lead

Lonza; Portsmouth (NH); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision insurance

Career development opportunities

Collaborative team environment

Resumo da oferta

Lonza in Portsmouth, NH is seeking a QA Specialist V – Raw Materials to oversee supplier quality, raw materials, and related systems in a GMP manufacturing environment. You will ensure supplier qualification, material disposition, and investigations align with regulatory standards while supporting site quality objectives.

The role emphasizes collaboration across Manufacturing, Quality, Regulatory Affairs, and Supply Chain, with a focus on continuous improvement and audits.

Qualificações

• Experience in supplier quality, raw materials compliance, or QA in pharma/biotech environment.
• Strong knowledge of GMP regulations and quality systems in manufacturing.
• Experience with supplier qualification, supplier oversight, and risk management.
• Ability to lead investigations and assess quality risks.
• Strong communication across departments and stakeholders.

Responsabilidades

• Serve as supplier quality SPOC for Portsmouth and global initiatives.
• SME for supplier quality systems, agreements, oversight, and compliance.
• Act as Raw Materials Compliance SME during audits, inspections, and supplier audits.
• Provide raw materials compliance and incoming material oversight.
• Support investigations, deviations, and CAPA activities.
• Support technology transfers, process improvements, and supplier transitions.
• Drive implementation of global supplier quality standards and site quality objectives.
• Collaborate with Manufacturing, QC, Regulatory Affairs, and Global Supplier Quality teams.

Conhecimentos

Supplier quality

GMP knowledge

Quality systems

Investigations

Communication

Formação académica

Bachelor's degree in Life Sciences/Engineering or related field

Ferramentas

TrackWise

LIMS

Descrição da oferta de emprego

Lonza in Portsmouth, NH is seeking a QA Specialist V – Raw Materials to oversee supplier quality, raw materials, and related systems in a GMP manufacturing environment. You will ensure supplier qualification, material disposition, and investigations align with regulatory standards while supporting site quality objectives.

The role emphasizes collaboration across Manufacturing, Quality, Regulatory Affairs, and Supply Chain, with a focus on continuous improvement and audits.