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:

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of
  applicable industry experience OR
• MS in Life Sciences or Engineering and 3+ years of applicable
  experience OR
• PhD in Life Sciences or Engineering with 1+ years of applicable
  experience
• 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 education
  program

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.