Eclaro - Bothell, WA
posted 2 months ago
The Deviation Investigator is a critical role within the Manufacturing Sciences and Technology (MSAT) team at Eclaro's client, a leader in the Biopharmaceutical Industry located in Bothell, WA. This position is responsible for overseeing and managing deviation records through the electronic quality record management system. The Deviation Investigator will investigate various types of deviations, including No Impact, Minor, Major, and Critical deviations, to determine their root causes and corrective actions. The investigator must ensure that all written reports meet regulatory expectations in terms of technical merit and completeness. In this individual contributor role, the Deviation Investigator will operate cross-functionally, collecting necessary data and information related to manufacturing and laboratory investigations. This role is essential in determining corrective actions to prevent the recurrence of deviations. The Deviation Investigator will be a key player in the MSAT team, championing quality principles and compliance within the organization. The position requires a proactive approach to quality and continuous improvement, as well as the ability to anticipate and mitigate challenges that may arise during investigations. The Deviation Investigator will actively manage deviations to achieve right first time (RFT) outcomes and ensure timely phase completion, including the closure of deviations by their original due dates. This role involves collaboration with various stakeholders, including QA reviewers, subject matter experts (SMEs), and other necessary team members, to define and align on investigation plans and required data. The investigator will also facilitate the investigation and corrective action plan (CAPA) processes, ensuring that all actions are implemented effectively and on time.