Specialist Qa

Specialist QA with experience in regulated industries to:Perform Trackwise system queries, deviationsParticipate in triage processPerform oversight of the process and procedures/GMP tasksManage Change Controls and deviations for review and approval as QA contactWork with operations to resolve basic compliance discrepanciesKnowledge in Validations and Laboratory area and equipmentStrong organizational skills, including ability to follow assignments through to completion.Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.Requisitos:Doctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience orAssociate's degree and 10 years of directly related experience (Educational background in Life Science and/or Engineering).Bilingual (Spanish/English)Technical WritingMicrosoft Office spreadsheet and application skills and presentation knowledge.Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.Validated skill in working independently and to interact with all levels throughout the organization optimally.