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QA Engineer, LMS
QA Engineer, LMSFujifilm • Holly Springs, NC, US
QA Engineer, LMS

QA Engineer, LMS

Fujifilm • Holly Springs, NC, US
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Overview

Position Overview

The QA Engineer, Learning Management System (LMS) is responsible for collaborating alongside team members in the creation of curriculum, serving as a ComplianceWire Administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program. This role adheres to Good Manufacturing Practices (GMP) to ensure compliance with applicable legislation. The QA Engineer, LMS acts as a site ambassador to encourage, motivate, and assist in meeting deliverables and timelines. This role works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency across the network and drives continuous improvements for the area.

What You'll Do

  • Manages administrative side of ComplianceWire (serves as Administrator) to ensure users receive required and compliant training material
  • Owns and updates Learning Management Systems and processes to address general questions regarding learning techniques
  • Assigns training to users and performs quarterly audit of training system to ensure training is aligned with role and curricula
  • Assists with continual development of education program for GxP content in collaboration with other FDB sites to ensure adherence to relevant guidelines and procedures
  • Partners with team members and works with Area Management / Leadership to define training needs and goals to ensure they align with company goals
  • Collaborates with team members to develop overall training metrics to measure performance for the site and provides people leaders with monthly reports and metrics for their teams adherence. Ensures oversight and adherence to established KPIs
  • Collaborates with other Fujifilm Diosynth Biotechnologies sites to drive best practices and continuous improvements across the network.
  • Presents LMS materials and systems to auditors during inspections and audits and follows up on regulatory and audit commitments for the area to ensure implementation for the site
  • Performs other duties, as assigned

Minimum Requirements

  • High School degree with 7+ years' experience with Learning Management Systems (LMS) OR
  • Bachelor's degree with 5+ years' experience with Learning Management Systems (LMS) OR
  • Master's degree with 3+ years' experience with Learning Management Systems (LMS) OR
  • PhD in education or learning
  • 2+ years of experience working in a GMP regulated environment
  • Proficient in of MS Office suite
  • Preferred Requirements

  • Previous experience in a cGMP manufacturing operation facility or a highly regulated industry with Quality Risk Management principles
  • Experience with greenfield projects
  • Experience with delivering content, managing e-learning platforms, and content development (e.g., SOPs, instructional design, Classroom training, OJTs)
  • Experience with LMS (e.g., ComplianceWire Administration, Veeva Training)
  • Working knowledge of Smartsheet software
  • Physical and Work Environment Requirements

    Ability to stand for prolonged periods up to 60 minutes.

    Ability to sit for prolonged periods of time up to 240 minutes.

    Ability to conduct activities using repetitive motions that include writs, hands and / or fingers.

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    Qa Engineer • Holly Springs, NC, US

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