FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

Orchestrate, track, and maintain essential documentation to include but not limited to - SOPs, manufacturing records, specifications, change controls, third party records as they progress through, and eventually reside in, the document control system.  Innovation, initiative, and attention to detail are essential to identify deficiencies and improve the efficiency of information flow through the system. 

• Coordinate the review and revision of procedures, specifications and forms.
• Assist with preparation, formatting, distribution, routing, and maintenance of SOPs and other version controlled documents.
• Assist with review of data and logs generated by Quality Control, Facilities, Process Development and Manufacturing.
• Review and maintain employee training files. 
• Create and maintain various filing systems.
• Update QA logbooks, databases and document manuals.
• Remain cognizant of regulatory compliance requirements, guidelines, and trends.
• Perform other duties as required.

• Bachelor’s degree or equivalent experience with +2 years related experience in a GMP environment.
• Familiarity with documentation control systems (manual and/or computerized) and applicable FDA regulations governing them.
• Basic knowledge of cGMP.
• Excellent writing and proofreading skills.

FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.