Position Overview
Job Description
Insight Global is looking for an investigator for one of our top pharmaceutical clients to support their site in Morris Plains, NJ. This role will author and oversee deviations, investigations, CAPAs, and related reports to ensure closure within the established timelines for the manufacturing department.
This role opens deviations, assesses their criticality within required timeframes, and evaluates any potential product impact in alignment with batch release activities. The specialist authors and owns investigations from initiation through closure, applying process knowledge and root cause analysis tools to identify true root causes of product and process deviations. They ensure all critical and major investigations are robust, accurate, complete, and fully defendable, and they design and execute experiments or test runs as needed to support investigation findings. Working cross‑functionally, the specialist collaborates with Manufacturing, Quality Control, ...