QA Specialist, LMS Position Available In Wake, North Carolina

Position Overview 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. Company Overview Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at

FUJIFILM

Diosynth Biotechnologies 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

FUJIFILM

Diosynth Biotechnologies and help manufacture 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 we call Genki. Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. Job Description 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. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).