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IT Quality Systems Engineer

Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 17, 2023

Job Description:


Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.Summary: - The Information Technology Quality Engineer serves as the IT Administrator for Quality and/or Laboratory Information Systems.

External US

Essential Functions: -

  • Maintain and configure System Databases and Application Servers
  • Optimize system configurations to maximize performance and ensure availability
  • Participate in planning and implementation of system changes and upgrades
  • Perform periodic maintenance and systems review, including security roles, performance, and data integrity
  • Maintain close collaboration with Quality departments, including business system owners
  • Develop and maintain system documentation
  • Support internal and third-party inspections and audits (FDA, EMA, Clients, etc.)
  • Troubleshoot and resolve questions/problems with assigned applications
  • Resolves and/or coordinates the resolution of technical issues with assigned applications
  • Create documentation for assigned applications and internal processes (SOPs)
  • All other duties as assignedRequired Skills & Abilities:
    • Strong technical documentation skills
    • Broad knowledge of laboratory and quality processes.
    • IT Administration experience with any/all of the following Quality Systems:
    • Master Control Document Management System
    • Sparta Trackwise Quality Management System
    • Compliance Wire LMS
    • Blue Mountain Asset Management system
    • Smart QC
    • DocuSign
    • Microsoft SQL Database administration experience preferred
    • Microsoft SharePoint experience optional
    • Proficiency writing Oracle / Microsoft SQL Queries
    • Proficiency creating custom reports using Crystal Reports or similar documentation tools
    • Knowledge of the Software Development Life Cycle (SDLC) for regulated life sciences industries.Working Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to:
      • Experience prolonged sitting, standing, bending, stooping and stretching.
      • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
      • Regularly lift up to 20 pounds and lift up to 50 pounds on occasion.
      • Attendance is required. Minimum Qualifications:
        • S Degree in Information Technology, Chemistry, or Engineering with knowledge laboratory or quality assurance operations.
        • 3+ years of work experience in a cGMP/highly regulated environment, including understanding of Change Control, Computer Systems Validation, 21CFR/Part 11 compliance.We are an equal opportunity and affirmative action employer. - All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. -If an accommodation to the application process is needed, please e-mail or call 979-431-3500.#LI-SB2 -

Keywords: FUJIFILM Holdings America Corporation, College Station , IT Quality Systems Engineer, Other , College Station, Texas

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