GENERAL PURPOSE Provide QC support for general testing and administrative support for raw materials and finished products. Follow pertinent SOPs to ensure cGMP compliance. POSITION RESPONSIBILITIES Independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Able to write and execute validation protocols and reports per current industry standards. Must have familiarity with HPLC, GC, NIR, water activity, UV-Vis, ICP-MS/AA and other pertinent instrumentation. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies. Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols. Performs analysis of finished products, validation samples, in-process materials and raw materials, and testing according to the effective Specifications, protocols, Methods and Compendial monographs.
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Job Type
Full-time
Career Level
Mid Level