Senior Quality Assurance Associate / Quality Assurance Associate

Location
San Diego, CA, United States
Posted
Mar 25, 2021
Ref
465MW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking a motivated and talented Quality Assurance Associate to assure adherence to standard operating procedures, GXP guidelines, and applicable regulations. The ideal candidate must thrive in a fast-paced team environment and must have excellent attention to detail, communication, organizational abilities, and independent problem-solving skills. Candidates must have experience in a research or academic setting with a working knowledge of GXP regulations. Hands-on experience in a regulated environment and GXP Quality Systems is a plus. This is a full-time position initially reporting to the Associate Director, Quality Assurance, and is located at our corporate headquarters in San Diego, California.

Responsibilities:
• Process document changes through FATE's electronic document management system
• Issue batch records and production documents to support release of drug products and
materials
• Write, review, and revise standard operating procedures relating to Quality Systems
• Maintain Quality tracking systems for controlled documents and data
• Assist in complaint, OOS, and deviation investigations
• Review and release raw materials according to FATE's material control program
• Proactively maintain an understanding of regulations and best practices for a robust Quality Management System e.g. FDA, USP, ICH, etc.
• Provide administrative support and assist with timeline tracking and QA metrics
• Perform other Quality related duties as assigned

Qualifications
• Bachelor's degree and minimum of one year of Quality Assurance experience in the
Pharmaceutical/Biotechnology industry
• Experience with document control standards, practices, and principals
• Experience in maintaining GXP training records
• Experience in data gathering, metrics development, and report generation
• Experience with databases with expertise in the Microsoft suite (e.g. PowerPoint, Word,
and Excel)
• Good organizational, project management skills and ability to perform varied tasks in a
functionally independent and consistent manner
• Ability to analyze, interpret technical procedures and regulations; experience in writing
procedures
• Ability to influence and collaborate with others; detail and results oriented
• Strong organizational, analytical, and problem-solving skills
• Strong team orientation, with excellent written and oral communication skills

Working Conditions and Physical Requirements
• May require occasional evening and weekend work
• May require occasional travel

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to careers@fatetherapeutics.com and reference job code 465MW.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.