Description
Designs, evaluates, implements and maintains quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements. Develops methods and protocols to ensure that appropriate quality assays and/or tests are being conducted. Works with quality and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards. Participates on new product and process design, development and implementation teams. Performs statistical analysis to analyze trends, and works with manufacturing to investigate trends, conduct root cause analysis and recommend corrective actions for processes and products. Assures the development and utilization of equipment calibration and preventative maintenance systems. Tracks and initiates investigation of complaint trends. Manages the Corrective and Preventative Action (CAPA) system. Provides guidance for and assists with the process (re)validation activities. Responsible for the implementation and management of the internal Quality Audit procedure and schedule. Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods. Represents the site quality systems to customers in face-to-face meetings or through written and verbal correspondence. May be required to perform other related duties as required and/or assigned. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Requires familiarity of cGMP.s and regulations applicable to the FDA. Normally receives no instructions on routine work, general instructions on new assignments. Requires strong, persuasive communication skills both verbally and in writing.To find out more about Real please visit www.realstaffing.com