Quality Assurance Associate III, Quality Systems

Location
San Diego, CA
Posted
Dec 02, 2021
Ref
567MM
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Description:

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 regulated environment and GxP Quality Systems. This is a full-time position reporting to the Associate Director, Quality Assurance, and is located at our corporate headquarters in San Diego, California.

Responsibilities:

  • Develop, enhance, manage, maintain, and track Quality Systems processes such as Deviations, CAPAs, Change Controls, and Periodic Reviews
  • Develop, Collect, and communicate Quality Systems metrics and reports to Quality Senior Management for review
  • Lead/support the development and improvement of the Quality Management System (QMS)
  • Write, revise, and review Standard Operating Procedures (SOPs) and Quality Systems related validation documentation
  • Perform validation testing as required for systems implementation
  • Maintain systems used for tracking various activities
  • Perform document and change control activities according to established procedures
  • Provide the required support during regulatory and internal audits
  • Perform other Quality Systems related duties as assigned

Qualifications:

  • Bachelors degree in a relevant scientific discipline and a minimum of 3 years of Quality Assurance or Quality Systems experience in the Pharmaceutical/Biotechnology industry
  • Good organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members
  • Strong background in computerized systems such as Veeva Vault, ComplianceWire, LIMS, etc., and Microsoft Office suite
  • Comprehensive knowledge of cGMP regulations and guidelines
  • Strong attention to detail, team orientation with excellent written and oral 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.
  • 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.