Raw Material Sampler 3

Fujifilm•Holly Springs, NC

35d•Onsite

About The Position

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs). 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

Ability to use respiratory and required PPE for dispensing
Knowledge of GMP and good distribution practice (GDP)
Intermediate knowledge of SAP material transactions and reports
Intermediate knowledge of LIMS and sample management
Intermediate understanding of cold chain and hazardous material handling
Knowledge of ERP for ordering and receiving warehouse materials
Intermediate understanding of sampling specifications
Ability to work shift work or weekend hours to support 24/7 operations and/or required to fulfill on-call responsibilities, as needed
High School Diploma or GED with 6 years related experience in a manufacturing environment; or
Associate’s Degree in Life Sciences or similar area with 4 years of related experience in a manufacturing environment; or
Bachelor’s Degree with 2 years related experience in a manufacturing environment or Military experience of equivalence
Experience with analytical and bench top scales
Previous weigh and dispense or raw material sampling experience

Nice To Haves

Prior experience operating industrial trucks
Experience with ERPs and LIMS, SAP and Labware
Previous GMP experience in a QC or sampling role
Experience training other associates
Bioworks or BTEC Capstone cGMP coursework

Responsibilities

Assists in the preparation for operational readiness including but not limited to creating and implementing new SOPs, development or transfer of warehouse business processes, testing and commissioning support with validation, and start-up activities with SAP ERP
Completes interim responsibilities (e.g., attending Integrated Working Team (IWT) meetings, owning IWT milestones, ordering supplies and owner equipment, supporting CQV activities) for operational readiness at the FDBN large scale greenfield site
Travels up to 25% (international or domestic)
Transfers materials into and out of Raw Material Sampling using powered or manual industrial trucks (PIT)
Performs Grade D gowning and material transfers
Performs sampling operations per material specifications
Interfaces with Warehouse, supervision, Supply Chain and QC
Identifies issues and suggests resolutions
Uses analytical and bench top scales in sampling booths
Interfaces with warehouse and supervision
Identifies issues operations, equipment, systems, procedures, and initiates corrective action for resolution
Executes cycle counting material in Raw Material Sampling
Identifies and maintains inventory levels for efficient sample throughput and scheduling
Troubleshoots inventory discrepancies
Trains lower-level associates on Raw Material Sampling operations
Leads department GEMBA and safety walks
Fills in for Lead Associate, as needed
Acts as the Subject Matter Expert (SME) for Raw Material Sampling operations, as defined by leadership
Leads departmental continuous improvement efforts, as directed
Other duties, as assigned