Analyst, Quality Control Sample Control
About The Position
The Quality Control Sample Control Analyst works under the 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 Fujifilm Biotechnologies and samples and reference materials from external sources. This role is primarily responsible for collecting and aliquoting samples. This role is also responsible for coordinating with key internal stakeholders the transport of QC samples from Fujifilm Biotechnologies to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into the sample handling process. This role includes 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
Requirements
- B.S./B.A. in relevant scientific discipline, preferably Chemistry,
- Biochemistry, Microbiology, Biology or Life Sciences
- 0-3 years laboratory experience
- Must be available to work weekends as part of your work schedule
Nice To Haves
- GMP laboratory experience
- Experience with LIMS software
Responsibilities
- Supports Sample Control team will provide sample collections 7 days a week when in Operations
- Supports Sample Control team to maintain and support equipment alarms during off hours and move samples as required, which may including routine on-call and weekend support, as needed
- Supports the setup of the Sample Management lab during Project phase including authoring procedures, sample collection in support of facility qualification, ordering lab supplies for QC department, logbook creation for QC, and additional activities, as needed
- Facilitates the movement of QC samples from Manufacturing to the QC labs maintaining sample chain of custody and GMP documentation
- Receives, inspects, and inventories reference materials and samples from external sources
- Documents sample 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 sample issues that arise from manufacturing, laboratories, or the warehouse
- Assist in authoring SOPs, protocols and reports related to Sample Management
- Supports continuous improvement projects and SOP revisions by providing input into the process and supports associated procedural updates
- Maintains sample integrity in all aspects of working with samples and reference materials
- Performs other duties, as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
