Senior Analyst 1, Quality Control Sample Control (Friday to Monday)

Position Overview

The Sr. Analyst 1, QC Sample Control works independently with limited supervision and guidance from their manager to ensure all samples managed by the Sample Control team are handled and documented in accordance with applicable internal procedures. This role is responsible for handling samples manufactured at FDB Holly Springs, samples and reference materials from external sources, coordinating stability samples and protocols within the sample control team. This role is also responsible for coordinating with key internal stakeholders on the transport of QC samples from Holly Springs to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into the sample handling process. A very high attention to detail and the ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

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

Responsibilities:

 

• Executes setup of Sample Management lab including authoring procedures, sample collection in support of facility qualification, determining lab supplies for QC department, logbook creation for QC, and additional activities, as needed
• Manages and performs daily sample collections to support utility PQ and cleaning validation studies. Executes sample reconciliation to ensure all samples were collected as per approved LIMS plan or protocol
• Maintains and supports equipment alarms during off hours and move samples, as required
• Executes movement of QC samples from Manufacturing to the QC labs and maintains sample chain of custody and GMP documentation
• Serves as advisor for program management by overseeing Stability Sample Sets, proper storage conditions and pulling samples per approved protocols and internal procedures to ensure proper management of all on-going studies in accordance with ICH guidelines and client requirements
• Receives, inspects, and inventories reference materials and samples from external sources. Will handle temperature excursion alerts to client if necessary
• Documents receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks
• Collaborates cross-functionally to address issues that arise from manufacturing, laboratories, or the warehouse
• Authors and reviews SOPs, protocols, reports, change management reports, CAPAs and Trackwise deviations related to Sample Management and Stability Studies
• Creates CoA’s and result summary reports to support batch disposition
• Participates in continuous improvement projects and SOP revisions by contributing input to the process, and supports associated procedural updates
• Ensures sample integrity in all aspects of working with samples and reference materials
• Assist in training new analysts, as needed
• Performs other duties, as assigned

 

Requirements:

 

• Excellent attention to detail. Seeks opportunities for improvement and suggests ideas for improvement projects
• Advanced technical writing and problem-solving skills
• Excellent verbal and written communication skills. Ability to review and interpret data
• Ability to present information to the team
• Ability to develop and assign tasks according to a structured plan.
• Ability to overcome and respond to challenges
• Ability to complete tasks independently and with occasional guidance from Supervision as needed
• Ability to implement structured plans
• Ability to support audits and client interactions
• Must be flexible to support 24/