QA Specialist

Quality Technician Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements. Major Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for carrying out tasks under direction of management and usually a contributor on broader goals. Develop compliant solutions to routine problems of limited scope. Responsible for demonstration of core competencies. Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Develops knowledge in such areas as incoming, in-process and final release testing, inspecting and/or processing and verifying work orders. Disposition incoming material for use in manufacturing and/or manufactured material for product for sale. Generates exception/CAPA documentation such as non-conformance reports reports required at the site for routine nonconformances. Knowledge of regulations and standards affecting IVDs and Biologics. Basic understanding of how their function supports the business. Basic understanding of technical/business competencies.

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