Quality Control Specialist Level 1

2 weken geleden


Geleen, Limburg, Nederland Lonza Voltijd

Overview: The Quality Control (QC) Associate Level 1 plays a critical role in ensuring that manufacturing areas, incoming materials, and utility supplies meet the required quality standards based on QC testing outcomes.

Key Responsibilities:

  • Plan and execute daily quality assessments and control measures while adhering to all applicable Good Manufacturing Practices (GMP) and safety regulations.
  • Engage in quality control activities specific to departmental responsibilities, which may include Cell Therapy, Environmental Monitoring, or Raw Materials.

Environmental Monitoring Duties:

  • Conduct quality control tasks as part of the Environmental Monitoring program.
  • Perform sampling in C and/or D grade cleanroom environments.
  • Document and interpret Environmental Monitoring results.
  • Maintain an organized database for Environmental Monitoring data.
  • Coordinate shipments for positive Environmental Monitoring samples for further identification.
  • Initiate Quality Events such as Non-Conformance Reports (NCs), Change Request Forms (CRFs), and Environmental Monitoring investigations.
  • Receive and process results from identification and investigations.

The QC Associate is primarily responsible for ensuring that the facility operates within controlled parameters for its designated use. Key activities include sampling, data collection, investigation, and reporting.



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