Analyst 1, All QC - Night Shift

Position Overview This position supports a 2/2/3 schedule from 6pm-6am. The Analyst, Quality Control (QC) All QC Team is responsible for performing routine testing requited for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC. 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 drive—what 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description What You’ll Do Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Supports environmental and utilities monitoring sample collection. Provides input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards. Coordinates testing materials and supplies. Plans and ensures materials are stocked. Partners with procurement, inventory management, and distribution to optimize laboratory operations. Ensures accuracy and security of laboratory information, implementing tools and protocols for data management. Conducts comprehensive reviews of laboratory testing results and provides analysis and interpretation of results, identifying trends and making informed recommendations. Under the direction of management, troubleshoots issues with laboratory assays and identifies underlying causes of assay failures and develops strategic solutions to improve test reliability. Leads general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies. Supports implementation and monitoring of CAPAs. Partners with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems. Participates in project developments from concept through execution, ensuring alignment with organizational goals. Performs additional duties, as needed. Knowledge, Skills, and Abilities Excellent attention to detail. Looks for opportunities for continuous improvement. Basic technical writing and problem-solving skills. Excellent verbal and written communication skills. Able to manage and complete tasks according to a structured plan. Able to complete tasks both independently and with occasional guidance from Supervision. Ability to support audit readiness for the laboratory. Self-driven, dedicated, and systematic and can plan your day in a structured way. Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself. Understanding of GMP, GLP, GDP requirements. Knowledgeable in basic sciences …

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