Overview
Quality Specialist GMP Jobs in Ghent, New York, USA at MindCapture
Location: Ghent
The Quality Specialist GMP is an exempt level position with responsibilities for providing quality oversight over the production of a personalised cell therapy to support both clinical and commercial requirements in a sterile GMP environment.
Serves as a quality specialist in plant in support of cell therapy manufacturing.
Ensures quality oversight in plant covering various process related activities.
Performs periodic quality checks/audits related to process, documentation and process manipulations.
Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures and batch records.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
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Title: Quality Specialist GMP
Company: MindCapture
Location: Ghent, New York, USA
Category: Quality Assurance – QA/QC, Healthcare (Data Scientist)
