QC Associate EM Level 2

Netherlands, Geleen

QC Associate - Environmental Monitoring Level 2

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Manufacturing areas, incoming materials and utility supplies and products are all released and approved for use based on QC test results as generated by the QC Associate. 

Activities of QC Associate Level 2 can differ per dedicated departmental responsibility whether the scope is Cell therapy, Environmental Monitoring

The Environmental Monitoring Associate 2 is mainly responsible to assure the facility is under control for its dedicated use. Sampling, gathering data, investigating and reporting are main responsibilities

Key responsibilities:

  • Perform quality activities as part of Environmental monitoring

  • Write, revise or review of documentation (e.g. EM sampling documentation, EM investigations,..) related to EM activities

  • Sampling of C and/or D grade cleanroom

  • Perform read-out and documentation of EM results

  • Maintain database for EM data

  • Request shipments to send out positive EM samples for identification

  • Initiation of Quality Events as NC’s, CRF’s and EM investigations

  • Receive results from identification and closure or investigations

  • Identify risks/ gaps within own work environment, provide input to improve and cooperate with the implementation of improvements

  • Has extensive practical and technical knowledge of methods and techniques

  • Participate during troubleshooting in related equipment/assay's

  • Take care of on-the-job training and provide subject matter support to colleagues

  • Act as trainer for specific QC topics

  • Backup of Senior QC associate

Key requirements:

  • The position requires a very precise and responsible working attitude.

  • Intermediate or higher vocational education in /microbiology/chemistry/biotechnology.

  • At least 2 years of experience with GMP and basic knowledge of incoming materials, EM, microbiological (gram stain, sterility)

  • Experience with preferable, investigations, document management, route cause analyses

  • Accuracy, tidiness, self-organized, flexible, attention to detail, team player.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R35933
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