QC associate Level 1
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 .
Responsible for planning and execution of daily quality assays and control activities while ensuring compliance with all existing GMP and safety standards in the area of responsibility.
Activities of QC Associate Level can differ per dedicated depart mental responsibility whether the scope is Cell therapy, Environmental Monitoring or Raw Materials .
Environmental Monitoring:
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Perform quality activities as part of Envir on mental monitoring
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Sampling of C and/or D grade cleanroom
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Perform read-out and documentation of EM results
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Maintain database for EM data
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Request shipments to send out positive EM samples for identification
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Initiation of Quality Events as NC’s, CRF’s and EM investigations
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Receive results from identification and closure or investigations
For EM, the associate is mainly responsible to assure the facility is under control for its dedicated use. Sampling, gathering data, investigating and reporting are main responsibilities.