QA Engineer, LMS

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.

Job Description

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 relevantguidelines and procedures

Partners with team members and works with Area Management / Leadership to define training needs and goals to ensure they align with companygoals

Collaborates with team members to develop overall training metrics to measure performance for the site and provides people leaders with monthlyreports 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 toensure implementation for the site

Performs other duties, as assigned

Minimum Requirements :

BS / BA in Life Sciences or Engineering or equivalent with 5+ years ofapplicable industry experience OR

MS in Life Sciences or Engineering and 3+ years of applicableexperience OR

PhD in Life Sciences or Engineering with 1+ years of applicableexperience

3+ years of experience working in a GMP regulated environment

Learning Management Software experience

Preferred Requirements :

5+ years of experience cGMP manufacturing operation facility

Experience with GxP greenfield projects

Experience with training content creation (SOPs, eLearnings, Classroom training, OJTs)

Veeva experience

ComplianceWire Administrator experience

Training and / or familiarity with Quality Risk Management principles

Experience delivering training and information relating to educationprogram

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.

Job Locations US-NC-Holly Springs

Posted Date 6 hours ago (10 / 2 / 2025 5 : 33 PM)

Requisition ID 2025-35796

Category Quality Assurance

Company (Portal Searching) Hidden (24213)