Overview
QA Investigator Jobs in Ghent, New York, USA at MindCapture
Location: Ghent
The QA Investigator is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
Key Responsibilities:
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Perform analysis on quality indicating data and identifying trends.
Collaborate with functional departments to resolve issues.
Manage cross-functional projects with many stakeholders.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
Drive continuous improvement.
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Title: QA Investigator
Company: MindCapture
Location: Ghent, New York, USA
Category: Quality Assurance – QA/QC