Quality Control Analyst II/III - Madison, WI
Cellular Dynamics International, a FujiFilm Company, is currently growing their quality team and is hiring for a Quality Control Analyst II/III. This position will perform daily quality control activities to support GMP Cell Therapy manufacturing.
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.
Some of the responsibilites are, but not limited to:
1. Develop and 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 and validate 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 use, maintenance and calibration.
8. Assist in equipment qualification activities.
9. Support QC functions for cleanroom operations including review and tracking of Environmental Monitoring data and cleanroom maintenance practices.
10. Assist in the ordering of lab supplies and maintenance of lab equipment.
11. Strictly adhere to SOPs and Good Documentation Practices.
12. Perform a technical review of raw data prior to audit by Quality Assurance.
13. Document laboratory deviations and investigations with minimal supervision.
14. Lead and support CAPA and continuous improvement initiatives.
15. Other duties as assigned.
Essential Job Requirements:
• BS in Biology or related field
• Experience working in a GMP lab is required
• 2-5 years of experience relevant to test method development with experience in flow cytometry and PCR
• In-depth knowledge of biology assays using flow cytometry and qPCR
• Ability to perform basic scientific math
• Experience in cell culture techniques
• Experience with Good Documentation Practices.
• Experience working in a cGMP-regulated field is required
• Excellent written and oral communication skills
• Expertise using MS WORD, Excel, and Access
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.