QA Specialist III

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.

Required experience includes: analytical problem solving techniques, ability to follow written controlled procedures, attention to details, basic computer/data management, good verbal and written communication skills. Highly desirable experience includes: knowledge of cGMP, GLP, CAPA and material/product traceability and control, manufacturing plant, operations, analytical chemistry, molecualr biology, statistical methods, research projects, team participation, laboratory testing and compliance, quality assurance experience, and understanding of basic clinical utility of products

Prefer candidates with medical device experience

This an entry level position.