Quality Control (QC) Analyst I

The QC Analyst I is responsible for determining quality of raw materials, intermediates and finished products using analytical methods and procedures as required. This position reports to the Quality Manager and works mainly the QC laboratory. The QC Analyst I performs numerous chemical assays using sophisticated instrumentation and interpret results with some supervision and must be able to observe proper procedures to ensure quality of finished goods and raw materials. The QC Analyst I is also responsible for meeting all other tasks assigned for their goals set by the Quality Manager. Responsibilities Duties: Analyzes raw materials, intermediates and products by physical, chemical and instrumental techniques in accordance with established procedures with some supervision. Ensures the laboratory is in working order, which includes but is not limited to keeping inventory of chemicals and consumables needed in the lab and calibrating equipment when needed. Submits accurate, precise and complete analytical reports in a timely fashion; Communicates OOS results. Reviews the work of colleagues and other departments as needed. Exhibits a working knowledge of Colorcon’s Oracle database applications to maintain accuracy of records. Aware of cGMPs and cGLPs and maintains compliance with those regulations; Documents all activities associated with cGMP compliance (i.e. instrument calibration, OOS investigations etc.) Demonstrates the ability to set priorities, with some supervision, based on Operation’s schedules and deadlines. Interdepartmental communication with operations (Operators and Shift Leaders) concerning the use of materials evaluated. Performs special analyses and special project testing on a request basis as needed. Assists with OOS investigations as needed. Maintains good housekeeping, order, and safety in the laboratory.