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Deviation Investigator

Wayne Metro Area, NJ

Posted: 02/20/2019 Job Type: Scientific Job Number: JN -022019-23726
Description:
Duties:

The deviation owner will lead the investigation of deviations that occur in operations and are responsible for authoring the investigation.
Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions.
Responsible for the closure of deviations.
Manage several investigations at a time.
Determine scope, product impact, root cause and corrective actions for deviations from procedures.
Determine appropriate preventative actions to prevent reoccurrence of the deviation, author deviations and conduct personnel interviews to determine root cause of the deviation.
Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.

Skills:
Technical Writing Skills.
Critical Thinking.
Proficient in the use of the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.
TrackWise experience.
Highly organized.
Time Management competent.
Capable of managing multiple priorities.
Excellent Communication Skills.
GxP Background.

Education:
Bachelor's Degree in Biology, Chemistry, or equivalent field with 5 years of experience working in deviations.
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