Senior Analyst 1, Quality Control Sample Control

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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.

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 CoAs 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:

• Bachelors degree in Science preferably Chemistry Biochemistry Microbiology Biology or Life Sciences relevant scientific discipline with 2 years of relevant experience OR
• Masters 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 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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Fujifilm is committedto 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.

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 ().