Senior Quality Assurance Specialist

il y a 6 jours


Mechelen, Flandre, Belgique Biocartis Temps plein
Job Description

The OMPS/QC Engineer plays a crucial role in supporting QC operations, ensuring the smooth transfer of activities from development to QC Operations. Key responsibilities include setting up and maintaining QC infrastructure, processes, procedures, and methods for incoming materials, semi-finished products, and finished products.

Supporting event investigations (e.g., NCR/CAPA) and improvement actions related to assay or manufacturing performance is also essential. The OMPS/QC Engineer contributes to root cause analysis (RCA) of event investigations and implements corrective and preventive actions.

Key Responsibilities:

  • Perform QC lab investigations for Out of Specification (OOS) results and trend analysis.
  • Recommend issue resolution, including both corrective and preventive actions, and ensure implementation in collaboration with process owners.
  • Follow policies, SOPs, and guidelines concerning safety, quality, working conditions, and environment.
  • Analyze events, perform Root Cause Analysis (RCA), develop, and verify solutions using scientific methodology and a structured approach.
  • Document findings, conclusions, and recommendations in line with quality regulations.


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