Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and supplier of human cells used in basic and translational research, drug discovery, toxicity testing, and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, CDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. The company’s inventoried iCell® products and donor-specific MyCell® Products are available in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. For more information please visit www.cellulardynamics.com. 

Cellular Dynamics International, a FujiFilm Company, is recruiting for a Quality Assurance Senior Scientist, Product Quality. This position will provide quality assurance expertise and guidance on appropriate technical controls and measures to ensure consistent product quality. Guide employees on appropriate quality system procedures directly related to product quality. 

Enjoy science but you don't want to be at the bench? Are you curious and a problem solver?  We are looking for an experienced cell or molecular biologist with an understanding of Quality Systems to join our team as a Quality Assurance team member with a focus on product quality and a commitment to excellence. 

Essential Job Responsibilities:
1.    Provide quality assurance and technical expertise to new product introduction teams, custom product teams, product change control teams, complaint investigation, and internal investigations.
2.    Work with teams to identify appropriate in-process QC tests and controls to achieve consistent product with consistent yields. Use technical expertise to evaluate scientific validity of data, requirements and specifications, quality control tests, and outcomes of investigations.
3.    Review final documents and records for scientific accuracy, and adherence to Quality System procedures to include but not limited to new product introduction records, product change control records, corrective and preventive actions, work instructions, labels, SOPs, batch records, deviations and investigations.
4.    Provide training and guidance to employees on quality system processes.
5.    Lead and/or participate in teams to drive improvements to product quality, processes, and the Quality System, including root cause investigations and corrective actions.
6.    Other occasional duties as assigned, provide back-up support for other QA staff.

Essential Job Requirements:

•    Bachelor’s degree in biology, or related academic field.
•    5 years of relevant industry experience in Cell Biology, Molecular Biology, Biochemistry, or related scientific field, to include at least two years in Quality Assurance with an emphasis on new product development and transfer to manufacturing.
•    Demonstrated achievements and progressive responsibilities and with an emphasis on developmental biology, cell culture and cell imaging.
•    Demonstrated performance and proficiency working under ISO9001, ISO13485, or cGMP.
•    Stem cell experience preferred.
•    Must be able to travel and work remotely occasionally.

Cellular Dynamics International 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.