QA Specialist II-Raw Materials Compliance

Lonza • Portsmouth, NH

9d • Onsite

About The Position

The QA Specialist II - Raw Materials Compliance plays a critical role in ensuring the quality, compliance, and availability of raw materials supporting the manufacture of life-changing therapies. The role works cross-functionally to address quality challenges and influence material compliance throughout the product lifecycle, while helping maintain uninterrupted operations, drive continuous improvement, and support inspection readiness.

The position partners with Quality, Supply Chain, Logistics, Manufacturing Science & Technology (MSAT), and other stakeholders. Responsibilities include raw-material quality release and documentation review, guidance on GDP and material controls, support for quality events and investigations, and training stakeholders on raw-material quality requirements.

Requirements

• Bachelor's degree required.
• Minimum 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, including the ability to identify quality risks and improvement opportunities.
• Effective communication, collaboration, and stakeholder-management skills in a regulated environment.

Nice To Haves

• Science or engineering background.

Responsibilities

• Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results.
• Review supplier and manufacturer documentation for 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 and help implement sustainable compliance solutions.
• Develop and deliver training and provide support and guidance on raw-material quality requirements to cross-functional stakeholders.

Benefits

• Medical, dental, and vision insurance.
• Opportunities to expand expertise in quality systems and raw-material compliance.
• Opportunities to grow and develop your career.
• Compensation programs that recognize high performance.
• Collaborative and quality-focused work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level