Quality Assurance Associate III / II, Manufacturing Operations

Location
San Diego, CA
Posted
Dec 03, 2021
Ref
622HH
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Description:

Fate Therapeutics is seeking a motivated and talented Quality Assurance Associate III/II 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 working in a cGMP environment and have hands-on experience in electronic Quality Systems. This is a full-time position reporting to the Manager, Quality Assurance, and is located at our corporate headquarters in San Diego, California.

Responsibilities:

  • Write, review, and revise standard operating procedures relating to Quality Systems.
  • Process document changes through FATEs electronic document management system.
  • Issue and review batch record and production documents to support release of drug products and materials.
  • Maintain Quality tracking systems for controlled documents and data.
  • Participate in Complaint, OOS, and deviation investigations and lead closure of associated documentation including performing CAPA effectiveness checks.
  • Assess effectiveness of current QMS procedures, implement improvements, and participate in the implementation of new e-QMS programs.
  • Review and release raw materials according to FATEs 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.

Qualifications:

  • Bachelors degree and minimum of two years of relevant Quality Assurance experience in the Pharmaceutical/Biotechnology industry, or equivalent education and experience
  • Comprehensive knowledge of Document Control standards, practices, and principles
  • Experience with a hard copy quality management system with planning for integration to an electronic document management system
  • Experience in maintaining GXP training records, materials, or courses
  • 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 and interpret technical procedures and regulations. Experience in writing procedures is a plus.
  • Ability to influence and collaborate with others
  • 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.

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.