Senior QA Specialist: Raw Materials Compliance

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Career growth

Medical, dental, and vision insurance

Cross-functional exposure

Competitive compensation

Job summary

Lonza in Portsmouth, NH is seeking a QA Specialist II - Raw Materials Compliance to ensure quality, compliance, and availability of raw materials for life-changing therapies. You will partner with Quality, Supply Chain, Logistics, MSAT and other stakeholders to maintain uninterrupted operations while driving continuous improvement and inspection readiness.

The role emphasizes GDP compliance, material receipt controls, and quality documentation practices, with opportunities to train

Qualifications

• 5+ years of quality experience in a regulated industry.
• Strong knowledge of cGMP, GDP, and quality system requirements.
• Experience reviewing technical documentation, specifications, certificates, and quality records.
• Strong attention to detail, organizational skills, and documentation review capabilities.
• Proven problem-solving skills with the ability to identify quality risks and improvement opportunities.
• Effective communication, collaboration, and stakeholder management skills in a regulated environment.

Responsibilities

• Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results.
• Review supplier and manufacturer documentation to ensure accuracy, completeness, and compliance with approved requirements.
• Provide guidance on GDP compliance, material receipt and disposition activities, inventory controls, and quality documentation practices.
• Partner with QA, QC, Supply Chain, Logistics, and MSAT teams to resolve material-related issues and support timely material availability.
• Support investigations, deviations, and quality events by providing expertise in raw material quality and compliance requirements.
• Identify quality risks and process improvement opportunities while helping implement sustainable compliance solutions.
• Develop and deliver training while providing support and guidance on raw material quality requirements to cross-functional stakeholders

Skills

Quality assurance

Regulated industry experience

cGMP & GDP knowledge

Documentation review

Problem solving

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in science or engineering

Job description

Lonza in Portsmouth, NH is seeking a QA Specialist II - Raw Materials Compliance to ensure quality, compliance, and availability of raw materials for life-changing therapies. You will partner with Quality, Supply Chain, Logistics, MSAT and other stakeholders to maintain uninterrupted operations while driving continuous improvement and inspection readiness.

The role emphasizes GDP compliance, material receipt controls, and quality documentation practices, with opportunities to train