Quality Assurance Associate
CurrentUphold of current Good Manufacturing Practices and adherence to the Quality Management System.Revision of Certificates of Analysis, Certificates of Compliance, other documentation for completeness and correctness as per applicable procedures to approve or reject product lots. Completion and maintenance of appropriate documentation to support the disposition of product lots.Completion of reviews of significant Deviation Investigations received, as defined in the Quality Agreement, to confirm that they meet the minimum requirements defined in the Company’s SOP.Communication with the contract facility management as necessary to ensure the timely completion of required activities.Revision of finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements.Assuring that appropriate process validation and stability studies are conducted.Writing and revision of technical and quality system documents such as Change Controls and Deviation Reports, as needed.