Analyst, Quality Control Sample Control

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

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 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: Description

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.

Education/Experience 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

Education/Experience Preferred:

GMP laboratory experience
Experience with LIMS software

Physical Requirements & Environmental Conditions:

Ability to discern audio cues.
Ability to inspect or perform a task with 20/20 corrected vision visual activity including distinguishing color
Ability to stand for prolong periods of time up to 60 minutes
Ability to sit for prolong periods of time up to 60 minutes
Ability to conduct activities using repetitive motions that include writs 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 twisting motions
Will work in 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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EEO Information

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.

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 ().

Required Experience:

Position OverviewThe 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...