Quality Assurance Specialist

Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Overview The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ensure timely availability for manufacturing. Serving as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, this role resolves material-related issues and escalations, conducts quality impact assessments for investigations, change controls, and supplier change notifications, and ensures compliance with applicable procedures and data integrity requirements. What You'll Do Execute QA disposition of GMP raw materials and consumables to support manufacturing schedules. Update and manage material status and associated records in SAP. Contribute to and review quality system records (e.g., deviations, change management, change controls) in TrackWise. Perform quality impact assessments for investigations and supplier change notifications related to raw materials/consumables. Collaborate with Warehouse, Supply Chain, QC Raw Materials, and Quality leadership to resolve issues, drive timely decisions, and maintain flow of materials. Review and adhere to applicable SOPs and work instructions; identify and support procedural improvements. Uphold data integrity and ensure compliance with 21 CFR Part 820 and Part 11, and internal quality standards. Minimum Qualifications High School Diploma or equivalent with 9+ years applicable industry experience; OR Associate's degree with 7+ years; OR Bachelor's degree with 5+ years; OR Master's degree with 3+ years. Hands‑on experience with SAP (material status/transactions) and Microsoft Office. Experience working within GMP quality systems (deviations, change control, investigations). Strong written and verbal communication, organization, critical thinking, and attention to detail. Demonstrated ability to multitask, prioritize, and meet timelines in a GMP environment. Preferred Qualifications Bachelor's degree with 5+ years applicable industry experience. TrackWise experience for deviations and change management. Supplier quality and/or material control experience in a regulated manufacturing environment. Proven ability to influence and collaborate across Supply Chain, QC, and QA. Key Skills Quality systems (investigations, change control), data integrity, problem solving, conflict resolution. Cross‑functional stakeholder management; ability to work independently with minimal daily direction. Agility and flexibility in a fast‑paced, schedule‑driven environment. Work Environment and Physical Requirements Primarily office‑based with standard computer work; hybrid eligible. May require moving objects up to 10 lbs. Generally does not require PPE for respiratory/hearing; limited exposure to production spaces as needed. Benefits Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life‑work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth! EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr