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QA Learning Specialist

FUJIFILM Diosynth Biotechnologies

This is a Contract position in San Francisco, CA posted January 1, 2023.

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.

We are looking for a Learning Specialist that collaborates internally or externally to define learning needs and implementation for the site.

Ensure that project and operational quality objectives are met within desired timelines.

The position will actively seek opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency.

This role and the associated responsibilities will develop as the project matures, and startup activities evolve into operations This Learning Specialist will partner to design the curricula and learning assignments into the LMS for the site to determine responsibility while ensuring alignment, where appropriate, implementation and maintenance.

External US Job Responsibilities Knowledge of systems and processes to address general questions regarding learning techniques.

Maintain all responsibilities associated with the LMS database.

Lead in the setup and daily administration of the system.

Point of contact and maintain understanding of the training program and how it applies to the site.

Assists Fujifilm Diosynth personnel with administrative course plan development, training Assist and function to perform assessments of change control for training impact.

Support client/regulatory audit activities as needed.

Proficient in LMS system configuration and reporting (ComplianceWire preferred) Provide updates/metrics to leadership, as required Working with area management to define training needs.

Requirements We are looking for a candidate with the following background and skill sets: Minimum Associate degree and 3 years experience in a cGMP manufacturing operation and/or Quality oversight, in an FDA regulated facility, is required.

Learning Management Software (LMS) experience required ComplianceWire experience (preferred) MS Office skills required SOP Writing skill (preferred) Master Controls experience (preferred) Working knowledge of Smartsheet software is a plus Preferred Skills Occasional opportunity for International and/or Domestic travel may be available Training and/or familiarity with Quality Risk Management principles preferred FDBN works with technical data, technology and materials that are subject to U.S.

export laws and regulations.

This position will require access to technical data, technology and source code that is controlled under U.S.

export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R.

Parts 120 – 130 and Export Administration Regulations in 15 C.F.R.

Part 730 – 774, as may be amended.

To conform to these laws and regulations, applicants must be U.S.

citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S.

Department of State or U.S.

Department of Commerce.

Offers of employment will be contingent on the Company’s ability to secure an export authorization.

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 lena.leefujifilm.com.

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.