Quality Assurance Associate III / II, Analytical Quality

Location
San Diego, CA
Posted
Dec 08, 2021
Ref
596CK
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Description:

Fate Therapeutics is seeking a motivated and talented individual 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 laboratory experience in an academic or industry setting with a working knowledge of cGMP regulations. Experience working in a cGMP environment and GxP Quality Systems is a plus. This is a full-time position reporting to the Senior Manager, Analytical Quality Assurance, and is located at our corporate headquarters in San Diego, California.

Responsibilities:

  • Review analytical data and documentation including raw data, test methods, protocols, and reports for accuracy, completeness, and compliance in a timely manner
  • Review and report unusual or out-of-specification testing results
  • Review supporting documentation including laboratory notebooks and associated documents to ensure traceability to raw data and verify all reagents, standards and equipment used are within the acceptance range
  • Ensure analysts follow all applicable SOPs and cGMP regulations and work with analysts for document corrections and provide guidance accordingly
  • Issue and review batch production documents to support disposition of drug products and materials
  • Provide QA oversight and review for investigation of OOS events and deviations
  • Maintain databases and systems used for tracking various activities
  • Write, revise, and review Standard Operating Procedures (SOPs)
  • Perform document and change control activities according to established procedures
  • Provide the required support during regulatory and internal audits
  • Perform other Quality-related duties as assigned

Qualifications:

  • Bachelors degree in a relevant scientific discipline and a minimum of 2-3 years of Quality Assurance or Quality Control experience in the Pharmaceutical/Biotechnology industry. Experience with cell-based assays or cell therapy products is preferred.
  • Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members
  • Strong background in analytical methods and testing, and related instrumentation, flow cytometry and PCR experience is a plus
  • Working knowledge of cGMP regulations (21 CFR Part 11, 211 and 210) and guidelines (FDA/ICH) and industry/technology standard practices for analytical methods.
  • 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.