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

We are recruiting for the new role of Supplier Quality Engineer to support our continued growth and on-going development projects.  Qualified individuals need have the capability, and to be inspired to support both the development of therapeutics (cGMP) and life science (non-cGMP) products and tools to support research endeavors .  We aspire to improve the quality of life through our efforts.  In return we provide development and support to enhance your career using cutting edge iPSC technology. 

In this highly critical and visible role you'll ensure compliance of suppliers and materials with applicable regulations, guidelines, and quality standards.  You'll also function as primary contact with suppliers for quality, while working with cross functional groups internally for all aspects of supplier management including but not limited to qualification, change requests, nonconforming material and corrective action requests.  If you aspire to be a critical resource in creating and maintaining a culture of quality, compliance, and cost initiatives, we offer an exceptional and unique opportunity to fully develop your career potential.

Essential Job Functions

1. Lead evaluation and qualification activities of suppliers providing materials and services for FCDI.
2. Coordinate and effectively communicate with cross functional groups to address supplier change requests, non-conforming product issues, Supplier Corrective Actions, risk assessments related to materials/service and associated Quality System Documentation.
3. Lead supplier audits, compile and distribute findings to quality management, and recommend improvement and/or corrective actions as appropriate.
4. Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards associated with product manufacture and release.
5. Provide quality assurance expertise and guidance for new product development, manufacturing operations, supplier development, and product quality
6. Write, revise review and approve standard operating procedures.
7. Participate in regulatory inspections and/or external client audits.
8. Other job functions as assigned.

Qualifications

• Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology
• 3 years of relevant quality assurance experience, with focus on supplier quality preferred, with demonstrated achievements and progressive responsibilities.
• Demonstrated proficiency in performing necessary audits – with supplier quality auditing experience highly desirable.
• Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders.
• Proficiency with MS office suite of products
• Functional proficiency with an eQMS solution
• Ability to travel overnight to include 30% domestic travel annually, 5% international travel.
• Able to work at computer for extended periods of time

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.