DESCRIPTION: Performs a variety of qualitative and quantitative analytical assays to support raw material, in-process, intermediate and final product testing according to standard operating procedures and regulatory requirements. Performs laboratory operations necessary to support testing, such as reagent preparation/qualification, equipment and assay troubleshooting. Analyzes results and notifies Manager immediately of any out of specification or out of trend results. Candidate makes decisions regarding equipment trleshooting along with senior analysts or manager input.
MOST CRITICAL SKILLS NEEDED ARE: Technical experience and practical application of relevant analytical techniques such Karl Fisher, IR, UV,AA, general wet chemistry. Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies. Applicant should also have strong computer skills; a strong background using a LIMS system is desirable.