FUJIFILM
QA Specialist, Supplier Quality
FUJIFILM, Holly Springs, North Carolina, United States, 27540
Position Overview
The QA Specialist, Supplier Quality is responsible for the day-to-day activities of administering Supplier Quality activities. This role acts as a point of contact for supplier quality and maintains supplier quality agreements, familiarity with audit programs, and vendor management processes. The QA Specialist, Supplier Quality administers approved supplier lists for the Holly Springs, NC site. This role collaborates internally with multiple QA teams, including Supplier Quality and site-based customers Supply Chain teams to manage and provide updates to suppliers. Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. 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." Job Description
What You'll Do Acts as workflow Subject Matter Expert (SME) for supplier management, assists the team with system updates, user support, problem solving and system training Supports QA Supplier Quality with governing processes and procedures within supplier management area Maintains oversight of TrackWise workflow for supplier management including quality agreement, vendor management, vendor changes and supplier complaints Drives timely closure for Quality metrics within Supplier Quality through dashboards and involves relevant team members, stakeholders, and external partners to ensure compliance and timely progress for records Authors and reviews QA procedures for supplier quality and Supply Chain areas, as assigned Ensures project and operational quality objectives are met within desired timelines Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency within area of responsibility Assists with and supports operational quality decisions and ensures proper escalation when necessary Identifies risks and communicates gaps for quality and GMP process/systems Performs other duties, as assigned Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable experience OR Master's in Life Sciences or Engineering or equivalent with 0 years of applicable experience OR 1-3 years' experience in a GMP environment Preferred Requirements: Experience working within a QA role Experience with TrackWise Physical and Work Environment Requirements: Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 120 minutes. Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet. * #LI-Onsite 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 (FDBN_PNC@fujifilm.com).
The QA Specialist, Supplier Quality is responsible for the day-to-day activities of administering Supplier Quality activities. This role acts as a point of contact for supplier quality and maintains supplier quality agreements, familiarity with audit programs, and vendor management processes. The QA Specialist, Supplier Quality administers approved supplier lists for the Holly Springs, NC site. This role collaborates internally with multiple QA teams, including Supplier Quality and site-based customers Supply Chain teams to manage and provide updates to suppliers. Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. 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." Job Description
What You'll Do Acts as workflow Subject Matter Expert (SME) for supplier management, assists the team with system updates, user support, problem solving and system training Supports QA Supplier Quality with governing processes and procedures within supplier management area Maintains oversight of TrackWise workflow for supplier management including quality agreement, vendor management, vendor changes and supplier complaints Drives timely closure for Quality metrics within Supplier Quality through dashboards and involves relevant team members, stakeholders, and external partners to ensure compliance and timely progress for records Authors and reviews QA procedures for supplier quality and Supply Chain areas, as assigned Ensures project and operational quality objectives are met within desired timelines Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency within area of responsibility Assists with and supports operational quality decisions and ensures proper escalation when necessary Identifies risks and communicates gaps for quality and GMP process/systems Performs other duties, as assigned Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable experience OR Master's in Life Sciences or Engineering or equivalent with 0 years of applicable experience OR 1-3 years' experience in a GMP environment Preferred Requirements: Experience working within a QA role Experience with TrackWise Physical and Work Environment Requirements: Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 120 minutes. Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet. * #LI-Onsite 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 (FDBN_PNC@fujifilm.com).