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CENTSTONE SERVICES LLC

Senior Quality Investigator

CENTSTONE SERVICES LLC, Baltimore, Maryland, United States, 21276


Job Title:

Senior Quality Investigator

Location:

Baltimore, MD

Duration:

5-6 Months

Responsibilities

Initiating and/or evaluating deviations.Interviewing personnel involved.Analyzing root causes and assessing impact.Identifying and implementing corrective/preventive actions.Presenting findings to management and closing investigations in the QMS.Executing root cause investigations.Owning/authoring deviations.Driving continuous improvement efforts.Managing minor and major investigations related to Batch Record reviews.

Experience

10+ years in managing quality investigations.

Scope Of Work

Managing Deviations, CAPAs (Corrective and Preventive Actions), and non-conformances.Conducting Root Cause Analysis.

Industry

Experience in Cell/Gene Therapy or Biologics is required.

Quality Systems

Essential experience with TrackWise and other Quality Management Systems (QMS).

Team Structure

Work as part of a team under a Senior Manager.

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