Quality Assurance Specialist I

Position Overview The Quality Assurance Specialist I is responsible for executing and supporting the routine QA systems at the Fujifilm New Castle site. This role ensures that all routine products consistently meet established business quality standards. The incumbent will manage documentation related to Controlled Documents, Management of Change (MOC), Training Records, Audits, and Sample Shipping. Additionally, the specialist will identify and escalate non‑routine or non‑compliance issues to the appropriate functional leads, maintaining strict adherence to quality protocols. GENERAL PURPOSE The Quality Assurance Specialist I is responsible for executing and supporting the routine QA systems at the Fujifilm New Castle site. The incumbent will manage documentation related to Controlled Documents, Management of Change (MOC), Training Records, Audits, and Sample Shipping. The specialist will identify and escalate non‑routine or non‑compliance issues to the appropriate functional leads, maintaining strict adherence to quality protocols. NATURE OF POSITION Reporting directly to the Quality Assurance Supervisor, this role supports all QA requirements across the New Castle production site. Key tasks include daily batch clearance of routine production products, conducting internal and external audits, responding to routine customer complaints, and identifying opportunities to enhance current QA systems. The Quality Assurance Specialist I will maintain comprehensive documentation for Quality Systems, identify system gaps or inefficiencies, and liaise cross‑functionally with departments such as Supply Chain, Production Support, Quality Control, Operations, Engineering, customers, and suppliers. Non‑compliance matters or issues beyond routine scope will be escalated to the QA Supervisor for resolution. Company Overview FUJIFILM Imaging Colorants is part of Fujifilm’s global Ink Solutions Group, developing aqueous dyes, pigment dispersions, and innovative inks for digital printing. Our manufacturing facility is located in New Castle, Delaware, a vibrant community with rich history and recreation. Fujifilm is headquartered in Tokyo and employs over 70,000 people worldwide. Job Description KEY RESPONSIBILITIES Execute routine batch clearance of base materials and finished products, including daily review of internal QC and manufacturing process results for compliance against specifications and approval of batch clearance. Perform routine physical inspection of finished goods prior to release. Review control limits for final products and specifications of base material and final products, relaying any issues to the QA Supervisor. Identify materials requiring formal batch review. Administer deviations of finished goods when necessary and coordinate with manufacturing, technical, QC, and other personnel through to completion. Progress all non‑conforming, questionable or non‑routine issues to the QA Supervisor, monitor non‑RFT finished goods, and document appropriately. Manage updating of QA status into SAP inventory records, generate and issue COAs, and arrange pre‑shipment samples and shipping documentation as appropriate. Participate in internal and external audits. Support the MOC process by performing actions as assigned, maintaining records, and updating MOC documentation with batch status. Act as the administrator for document control and training systems. Review and update QA procedures and work instructions as they relate to routine production and business needs. Identify opportunities for improvement of the QA systems and provide options and recommendations to resolve problems and issues resulting from QA investigations and audits. Education & Experience Minimum High School Diploma with 3‑5 years’ experience in quality assurance or relevant manufacturing environments. Required Skills and Competencies Strong interpersonal and communication skills. Highly organized with exceptional attention to detail. Ability to work independently and manage multiple priorities efficiently. Strong problem identification and escalation abilities. Proven data management capabilities. Proficiency with MS Office (Word, Excel, PowerPoint), LIMS, SAP, and aptitude to rapidly learn new software applications. Basic analytical and problem‑solving skills. Core Competencies Self‑Development Concern for Impact Initiative Results Orientation Job Specific Competencies Tenacity Critical Information Seeking Efficiency Orientation Analytical Thinking Concern for Standards Thoroughness Innovativeness 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 (cous‑View email address on click.appcast.io). #J-18808-Ljbffr