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Cylex (http://www.cylex.net ) is a global life sciences company focused on the development, manufacture and commercialization of in vitro diagnostic products intended to illuminate immunity in the area of transplant medicine. The Manufacturing Laboratory Technician is tasked with performing manufacturing and quality control activities within cGMP guidelines and according to all approved procedures. This position also provides assistance with inventory control, shipping, receiving, and validation activities as needed. Helps maintain the manufacturing data records within Microsoft Dynamics GP.
Essential Functions:
* Perform manufacturing, filling, labeling and packaging operations including transactions within MS Dynamics GP
* Properly operate the thermal transfer label printer and associated software in order to design and print labels for product and other uses
* Follow SOPs and cGMP guidelines to ensure product specifications are met
* Perform inventory control, shipping and receiving activities
* Perform quality control activities on raw material and manufactured products, including analyzing and interpreting results
* Assist with validation tasks related to manufacturing scale-up and automation
* Perform laboratory experiments and analyze data to assist with the qualification of alternate vendors for key raw materials
* Initiate changes to Manufacturing and Quality Control documentation
* Perform cross-functional technical responsibilities in product development including processing patient samples and analyzing results
* Other duties as assigned
Minimum Requirements:
* Associate degree or 1 year prior experience working in a cGMP laboratory or an equivalent combination of education and experience.
* Knowledge of basic laboratory equipment
* Knowledge of reagent processes, laboratory and production procedures
* Working knowledge of Microsoft Office suite
Ruth McCall
Accounting & HR Assistant
Cylex, Inc.
8980-I Old Annapolis Road
Columbia, MD USA 21045
[log in to unmask]
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