QA Associate

Novato, CA 94949

Posted: 08/29/2019 Employment Type: Contract Industry: Quality Job Number: 6776

QA Associate

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


Conduct laboratory, environmental monitoring (alert, action) and deviation investigations in the QC and QA Operations areas.

Facilitate investigation related meetings, including root cause analysis.

Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. These reports may be related to manufacturing, facilities, QA or QC related events.

Monitor trackwise record workflows and report metrics to area manager.

Skills: 

  • Minimum 3 years’ relevant experience in a cGMP regulated QC laboratory, with exhibited knowledge and proficiency in investigations (investigator and QA approver roles).
  • Experience and ability to work cross functionally as needed.
  • Experience in supporting Quality Operations is highly desirable.
  • Strong ability to facilitate investigational meetings autonomously.
  • Ability to track work and present metrics to management as needed.

Education:   

  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

 

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