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Quality Control Analyst

Quality Control Analyst performs the customer samples for Assay, raw material testing and finished drug product testing, using test methods based on the USP. Performs Impurity testing, Content uniformity & Blend uniformity of raw materials and In-process drugs. Performs laboratory operations with good dexterity, good laboratory techniques, and high degree of accuracy and precision. Write and verify IQ/OQ/PQ protocols and SOPs, participate in risk identification and mitigation for regulatory compliance. Ensure that the principals of design control are applied to product and process changes and new product development. Validates and calibrates instruments like HPLC, Dissolution, FTIR and UV-VIS Spectrophotometer. Perform defect analysis on components and finished products. Create and review quality system documents including trend analysis. Create Analytical method development and test method validation. Issue Certificates of Analysis for Raw Material, In-process, finished products and Stability samples. Check and manage inventories of supplies and raw materials. Must have at least a Master's degree in Chemical Engineering, Chemistry or in a related field. Must have completed coursework in: Advanced Chemical Engineering Math, Analytical Chemistry, and Optimization of Chemical Processes. Job Location: Branchburg, NJ.