QA Specialist II - Raw Materials ComplianceLocation: Portsmouth, NH (On-site)
As a QA Specialist II - Raw Materials Compliance, you will play a critical role in ensuring the quality, compliance, and availability of raw materials that support the manufacture of life-changing therapies.
This is an excellent opportunity for a quality professional who enjoys working cross-functionally, solving complex quality challenges, and influencing material compliance throughout the product lifecycle. You'll partner with Quality, Supply Chain, Logistics, Manufacturing Science & Technology (MSAT), and other stakeholders to help maintain uninterrupted operations while driving continuous improvement and inspection readiness.
What you will get- An agile career and dynamic working culture
- Opportunities to expand your expertise in quality systems and raw material compliance
- Exposure to cross-functional teams across Quality, Supply Chain, Logistics, and Manufacturing
- A collaborative and quality-focused work environment
- Compensation programs that recognize high performance
- Medical, dental, and vision insurance
- Opportunities to grow and develop your career
What you will do- 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
What we are looking for- Bachelor's degree required; science or engineering background preferred
- 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 with the ability to identify quality risks and improvement opportunities
- Effective communication, collaboration, and stakeholder management skills in a regulated environment
