QA Specialist, LMS

Overview

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 solutionsto 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.

External US

About This Role

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
• Assists with continual development of education program
• Collaborates alongside team to work with Area Management / Leadership to define training needs, goals and ensure they align with company
• Collaborates alongside team to develop overall training metrics
• Collaborates with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency
• Other duties, as assigned

Minimum Requirements

• High School Diploma or GED with 6 years’ experience in a cGMP manufacturing operation and / or Quality oversight, in an FDA regulated facility OR
• 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 no previous cGMP experience
• Learning Management Software (LMS) experience
• Proficient in of MS Office suite

Preferred Requirements

• 2-3 years’ experience 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
• 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 Environmental Requirements

• Ability to stand for prolonged periods of time 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

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please email .

To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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