QA Specialist V - Raw Materials
Lonza
Summary
The QA Specialist V - Raw Materials is responsible for providing Quality Assurance oversight of raw materials, consumables, single-use systems, supplier-provided services, and supplier quality systems supporting GMP manufacturing operations at the Portsmouth site. The role ensures supplier qualification activities, incoming material controls, supplier quality agreements, supplier investigations, quality risk assessments, and material disposition activities are conducted in accordance with applicable regulatory requirements, corporate standards, and site procedures.
Job description
This role follows an 8-hour day shift schedule from 8:00 AM to 4:30 PM Monday through Friday.
What you will do
- Function as a designated Portsmouth supplier quality point of contact (SPOC) supporting local and global supplier quality initiatives
- Serve as site Subject Matter Expert (SME) for supplier quality systems, quality agreements, supplier oversight, and supplier compliance requirements
- Serve as Raw Materials Compliance and Supplier Quality SME during customer audits, regulatory inspections, supplier audits, and internal audits
- Provide raw materials compliance and incoming material oversight
- Support investigations, supplier quality events, deviations, and corrective action activities
- Support technology transfers, new product introductions, process improvements, supplier transitions, and strategic quality initiatives
- Support implementation of global supplier quality standards and site quality objectives
- Drive a culture of quality, compliance, continuous improvement, and inspection readiness
- Collaborate with Manufacturing, Quality Control, Technical Services, Validation, Supply Chain, Procurement, Materials Management, Regulatory Affairs, and Global Supplier Quality teams to drive continuous improvement
What we are looking for
- Experience in supplier quality, raw materials compliance, or Quality Assurance within a pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy environment
- Strong knowledge of GMP regulations and quality systems in a manufacturing setting
- Experience supporting supplier qualification, supplier oversight, and risk management activities
- Ability to lead investigations, assess quality risks, and make informed quality decisions
- Strong communication skills with the ability to collaborate across multiple departments and stakeholders
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or a related field, or equivalent experience
- Experience with quality systems and electronic platforms such as TrackWise, LIMS, or similar applications is preferred
Requirements
- Experience in supplier quality, raw materials compliance, or Quality Assurance within a pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy environment
- Strong knowledge of GMP regulations and quality systems in a manufacturing setting
- Experience supporting supplier qualification, supplier oversight, and risk management activities
- Ability to lead investigations, assess quality risks, and make informed quality decisions
- Strong communication skills with the ability to collaborate across multiple departments and stakeholders
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or a related field, or equivalent experience
- Experience with quality systems and electronic platforms such as TrackWise, LIMS, or similar applications is preferred
Benefits
- Medical, Dental & Vision
- Career Development Opportunities
- Collaborative Team Environment
- Compensation Programs
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.