The QA Specialist, LMS is responsible for collaborating alongside current team members with the creation of curriculum, serving as ComplianceWire administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program, co-developer of internal PQS SharePoint site, overall site training ambassador to help encourage, motivating and assisting in meeting deliverables and timelines and more. Works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency.

What You'll Do

• Performs administrative side of ComplianceWire (serve as Administrator)
• Updates Learning Management Systems and processes to address general questions regarding learning techniques
• Assigns training to users, performs quarterly audit of training system to ensure training is aligned with role and curricula
• Identifies, evaluates, and owns continuous improvement opportunities for the Learning & Development team
• Uses discretion to make informed quality related decisions for the Learning & Development team
• Generates, reviews, and approves documentation, procedures, and processes for operational readiness and through cGMP operations as it pertains to Learning & Development
• Assists with continual development of education program
• Collaborates alongside team members to work with Area Management/Leadership to define training needs, goals and ensure they align with company
• Collaborates alongside team members to develop overall training metrics
• Collaborates with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency
• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree with 2+ years’ experience in a cGMP manufacturing operation and/or Quality oversight, in an FDA regulated facility OR
• Master’s degree with 0 years’ experience
• 1-3 years’ experience in a GMP environment
• Learning Management Software (LMS) experience
• Proficient in of MS Office suite

Preferred Requirements:

• Previous experience in a cGMP manufacturing operation facility
• Experience on at least 1 – 2 greenfield projects
• Experience with training content creation (SOPs, eLearnings, Classroom training, OJTs)
• MasterControl experience
• ComplianceWire Administrator experience
• Experience and working knowledge of Smartsheet software
• 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.