Analyst, All QC

Fujifilm•Holly Springs, NC

7d•Onsite

About The Position

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

Requirements

Bachelor’s degree in scientific discipline with 0-1 years of experience
Basic understanding of GMP, GLP, GDP requirements

Nice To Haves

2+ years of Intermediate experience in a GMP QC Laboratory, knowledge of all compendial test methods preferred
Ability to troubleshoot and maintain laboratory equipment and instrumentation

Responsibilities

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