Axelon
Quality Assurance
Axelon, San Francisco, California, United States, 94199
At least five years' experience in a quality role in an FDA-regulated industry such as cell therapy, biotechnology, pharmaceuticals, or medical devices.
Independence, planning, and decision-making abilities to complete assigned duties.
Knowledge of relevant Federal and State regulations and policies.
bility to solve problems and issues; listen, interpret, and confirm understanding of others' communications; and be objective.
Effective, efficient, and tactful oral and written communication skills.
Time management skills and the flexibility to accommodate changing priorities in the unit.
bility to work in a team-oriented setting, prioritize work, and follow through on routine assignments with minimal direction.
Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
Bachelor's degree in a related area and / or equivalent experience/training.
The Quality Assurance Specialist will, with the guidance of the program Head of QA, perform quality assurance activities for the Investigational Cellular Therapy Group, UCSF HICTF and GMP Facility, and the Pediatric Cellular Therapy Laboratory.These laboratories support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. Wedo not perform standard-of-care cellular therapy activities, such as hematopoietic stem cell transplants, which are handled by other facilities. The position involves working with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in thebiopharmaceutical industry that has collaborations or manufacturing activities ongoing with our group. Work is completed in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
Independence, planning, and decision-making abilities to complete assigned duties.
Knowledge of relevant Federal and State regulations and policies.
bility to solve problems and issues; listen, interpret, and confirm understanding of others' communications; and be objective.
Effective, efficient, and tactful oral and written communication skills.
Time management skills and the flexibility to accommodate changing priorities in the unit.
bility to work in a team-oriented setting, prioritize work, and follow through on routine assignments with minimal direction.
Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
Bachelor's degree in a related area and / or equivalent experience/training.
The Quality Assurance Specialist will, with the guidance of the program Head of QA, perform quality assurance activities for the Investigational Cellular Therapy Group, UCSF HICTF and GMP Facility, and the Pediatric Cellular Therapy Laboratory.These laboratories support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials. Wedo not perform standard-of-care cellular therapy activities, such as hematopoietic stem cell transplants, which are handled by other facilities. The position involves working with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in thebiopharmaceutical industry that has collaborations or manufacturing activities ongoing with our group. Work is completed in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.