Quality Control Analyst

Fujifilm Cellular Dynamics, Inc. (FCDI) is recruiting for an additional Quality Control Analyst to support our continued growth. The QC team supports manufacturing efforts that include cell therapy and research material for ocular, cardiac, autoimmune, oncological and neurological diseases. In this critical role we are looking for a self-motivated and collaborative individual with QC experience to be a part of our team. If you aspire to be a critical resource in creating and maintaining a culture of quality, compliance, and innovation, we offer an exceptional and unique opportunity to fully develop your career potential.

FCDI is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine.

Essential Job Functions:

1. Qualify Quality Control (QC) finished product test methods to support cell therapy programs.
2. Liaise with project teams to perform technology transfer for QC test methods and cell characterization assays.
3. Perform QC testing on cell therapeutics intended for pre-clinical animal studies and human clinical trials.
4. Work with project teams to establish reference standard materials to support cell therapy programs.
5. Perform studies to qualify QC test methods to support cell therapy production for pre-clinical animal studies and human clinical trials.
6. Draft and execute product stability protocols.
7. Write/review/revise SOPs related to Quality Control testing including test methods, equipment usage, maintenance and calibration.
8. Track and Trend QC results.
9. Assist in the inventory of lab supplies and maintenance of lab equipment, as required.
10. Strictly adhere to SOPs and Good Documentation Practices.
11. Perform technical reviews of raw data prior to audit by Quality Assurance.
12. Document laboratory deviations and investigations with minimal supervision.
13. Support CAPA and continuous improvement initiatives.
14. Other job functions as assigned.

Essential Job Requirements:

• Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology
• 5 years of relevant Quality Control experience to include proficiency in flow cytometry and/or qPCR, with demonstrated achievements and progressive responsibilities.
• Cell culture experience including strong background in aseptic behavior a must.
• Experience and demonstrated performance in a cGMP lab.
• Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders.
• Proficiency with MS office suite of products
• Ability to perform basic scientific math
• Functional proficiency with an electronic Quality Management System

Physical Requirements:

• Able to wear standard laboratory PPE
• Able to work in laboratory hood for extended periods of time.
• Able to work with hazardous materials (i.e. chemicals, electrical equipment and human tissue) without endangering oneself or others.