Position: Quality Assurance Specialist

Location: San Francisco, CA 94103

Duration: 22-week contract with a possible extension

Pay Rate: $40/hr - $46/hr (depending on experience)

SUMMARY

• Involves staffing, administering, or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest, and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.

Job Description:

• The Quality Assurance Specialist will, with the guidance of the program Head of QA, perform quality assurance activities for the Investigational Cellular Therapy Group, 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.
• The position involves working with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in the biopharmaceutical 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.
• Applies research compliance professional concepts to review protocols to ensure that all regulatory criteria are met, as well as policies and/or regulations from the organization, the state, and systemwide.
• Routine implementation of quality systems including document management, supplier qualification, record review, report monitoring and tracking, deviation investigation, and other processes per established procedures
• Participates in the development and revision of standard operating procedures and guidelines.
• Draft and revise Standard Operating Procedures
• Communicates directly with investigators to resolve all concerns as identified during the review process.
• Perform internal audits. Ensure readiness for inspections by the FDA and audits from funders and collaborators.
• Participates in training individuals and departments on relevant compliance processes, forms, and policies.
• Coordinate and maintain records of personnel training specific to cell therapy program operations
• Additional Tasks as assigned to ensure quality in cell therapy development and manufacturing activities.

Job Requirement:

• Bachelor's degree in related area and / or equivalent experience / training.
• 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.
• Ability to solve problems, 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 unit.
• Ability to work in a team oriented setting, to prioritize work, and to 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.