QA Specialist V - Raw Materials
About The Position
The QA Specialist V – Raw Materials provides 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 position ensures that supplier qualification activities, incoming material controls, supplier quality agreements, supplier investigations, quality risk assessments, and material disposition activities comply with applicable regulatory requirements, corporate standards, and site procedures. The role follows an 8-hour day shift schedule from 8:00 AM to 4:30 PM, Monday through Friday. The specialist serves as the Portsmouth supplier quality point of contact and site subject matter expert for supplier quality systems, agreements, oversight, and compliance requirements. The role also provides raw materials compliance and incoming material oversight, supports quality events and business initiatives, and promotes quality, compliance, continuous improvement, and inspection readiness. Lonza describes its workplace as collaborative, inclusive, ethical, and supportive, with opportunities for career growth and development. The company emphasizes its values of Collaboration, Accountability, Excellence, Passion, and Integrity, and provides equal employment opportunities to qualified applicants.
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 and ability to collaborate across multiple departments and stakeholders.
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or a related field, or equivalent experience.
Nice To Haves
- Experience with quality systems and electronic platforms such as TrackWise, LIMS, or similar applications.
Responsibilities
- Function as a designated Portsmouth supplier quality point of contact (SPOC) supporting local and global supplier quality initiatives.
- Serve as the site subject matter expert for supplier quality systems, quality agreements, supplier oversight, and supplier compliance requirements.
- Serve as the Raw Materials Compliance and Supplier Quality subject matter expert 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.
Benefits
- Medical, dental, and vision insurance.
- Opportunities to grow and develop your career.
- Compensation programs that recognize high performance.
- An inclusive and ethical workplace.
- A collaborative and supportive team environment.
- An agile career and dynamic working culture.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
