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QA Associate

Marin Metro Area, CA

Posted: 08/29/2019 Job Type: Scientific Job Number: JN -082019-25531

DUTIES:

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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