Document Control Associate, Quality Assurance

Fate’s Quality Assurance (QA) group is seeking a motivated and talented individual to support Document Control functions and assure adherence to standard operating procedures, GXP guidelines, and applicable regulations. The ideal candidate will have experience working in a cGMP environment and have hands-on experience in document management and control. Candidates must thrive in a fast-paced team environment and must have excellent attention to detail, communication, organizational abilities, and independent problem-solving skills. This is a full-time position reporting to the Associate Director, Quality Assurance, and is located at our company’s headquarters in San Diego, California. 


Responsibilities

• Day to day management of the Document Control program, including, but not limited to: 
oIssuance of batch records, labels, and logbooks 
oPerform document change control review and assessment. 
oDay-to-day management of all paper & electronic records, including filing, scanning, and offsite storage management 
oCreation/revision of Document Control and other quality-related SOPs 
oAssist with the daily management of the eDMS (Veeva Vault QualityDocs) 

• Write, revise, and review documents relating to QA/Document Control 
• 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 or Associate degree in a relevant scientific discipline a plus 
• At least 2 years prior hands-on experience with Document Control in the biotechnology or pharmaceutical industry that includes work on early stage products 
• Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members 
• Experience preparing and reviewing cGMP documentation in support of manufacturing operations 
• Working knowledge of 21 CFR Part 211 and 210, FDA/ICH guidelines, and industry/technology standard practices including GMP, GCP, and GTP 
• Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel 
• Strong attention to detail and communication skills 
• Able to work independently and prioritize tasks in a fast paced and dynamic environment 

Working Conditions and Physical Requirements

• May require occasional evening and weekend work.
• Full-time onsite work at company’s headquarters in San Diego.
• Frequently required to work on a computer up to 8 hours a day.
• Occasionally required to stoop, kneel, and lift up to 50 pounds. 

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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. 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 pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.