QA Specialist II - Raw Materials Compliance
Lonza
Summary
At Lonza, our greatest scientific solution is talented people working together to help improve lives around the world. 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.
Job description
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 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
Requirements
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Career Development
- Agile Work Culture
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.