QC Scientist II- Laboratory Systems
FujiFilm Diosynth Biotechnologies - Durham, NC

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Job Description
: The QC Scientist 2 is an independent contributor that takes direction from manager and matrix contributors regarding priority and strategy. They are responsible for well-defined projects that are task oriented and may be assigned as a project and client representative for QC. The individual may have some personnel oversight responsibilities as they relate to daily project execution activities. The individual designs and executes components of projects that include but are not limited to process and method improvement, analytical technology transfer, method qualification/validation, and other related laboratory initiatives. The QC Scientist 2 is specialized in multiple disciplines and contributes as a subject matter expert on those topics. The individual works with minimal direction and is responsible for achieving assigned milestones and project deliverables. The position has multiple project ownership and is responsible for execution and deliverables for all or part of the project components.

This position will have primary responsibility for the implementation and maintenance of the Laboratory Information Management System (LIMS). Short term responsibilities will focus on the implementation and validation of the LIMS systems. Long term responsibilities will focus on system administration and oversight for LIMS and other IT related laboratory data management systems.

As the responsibilities relate to the data management systems, such as the LIMS implementation, the major activities include, but are not limited to:

Configuring, customizing, maintaining and upgrading LIMS Building Master Data templates for LIMS Integrating instruments and equipment to LIMS or Empower Acting as a Point of Contact for IT and data management system end users Identifying and analyzing opportunities to improve the laboratory information management process Assisting with development and validation of new modules in LIMS. Providing end user support, assisting or training new users regarding system use, data entry, and reporting of data Configuring, customizing, maintaining and upgrading fields and modules within the data management systems May support other information management systems within the laboratory, such as FreezerPro, Empower, and validated spreadsheets. Maintaining currency of expertise and knowledge regarding the use and operation of the various systems. Responsible for system-related deviations and change controls. Sustains the systems used to collect, enter, verify, and maintain the necessary static data for the system Managing system updates and project time lines to support manufacturing and disposition schedules Other responsibilities and duties include but are not limited to:

Maintains a working knowledge of the laboratory processes, hardware and software components understanding how the method and its analysis relate to the process Assure campaign readiness regarding project milestones, developing documents such as protocols, test plans, summary reports, methods, procedures, and forms Acts as gatekeeper for assigned disciplines, assuring consistency to methods and forms that are transferred to QC Develops training curricula related to assigned disciplines and conducts end-user training. Designs and develops statistical applications for the monitoring and analysis of data Facilitates cross-functional process improvement projects and method transfers Maintains network within discipline area and maintains awareness of industry practices and trends regarding laboratory operations Maintains expertise through personal self-improvement efforts, such as current literature searches, networking, conferences or seminars Develops an understanding of how the method and analysis relate to the process and the product quality Achieves personal and team success by managing through influence and relationships building

Education Requirements: *
  • BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field

FujiFilm Diosynth Biotechnologies - 22 months ago - save job - copy to clipboard
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