Senior Analyst, Quality Control Sample Control (Saturday to Wednesday)

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:

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 24/7 manufacturing facility

Education/Experience Requirements:

• Bachelor's degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
• Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
• 3 years experience in a GMP environment

Education/Experience Preferred:

• 1 year of experience with the use of Labware LIMS and/or working with a LIMS in a cGMP Quality Control department or in an FDA regulated industry (drugs/biologics)
• Experience using Trackwise system
• Experience working in a laboratory environment is desired
• Basic familiarity with fundamental statistical tools to analyze data in relation to trends results
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

Physical Demands

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand up to 60 minutes at a time.
• Ability to sit up to 60 minutes at a time.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height and use a twisting motion.
• Will work in a small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).