Quality Assurance Associate Managert

Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. Responsible for review and investigations of Failures, Investigations and Deviations; ensuring corrective action implementation and associated summary reports. Compiled data for the investigations of Failures, Investigations and Deviations; ensuring corrective action implementation and associated summary reports. Recognized for strong scientific background, quality systems training, vendor qualifications and audit compliance to GMP, GLP, GXP. Work well independently or as a team member with a can-do attitude focused on meeting challenges and working co-operatively to achieve a common goal.

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