Specialist Qa - 33179

Job Description Qualified candidates please review the required expertise; • Perform Trackwise system queries, deviations • Participate in triage process • Perform oversight of the process and procedures/GMP tasks • Manage Change Controls and deviations for review and approval as QA contact • Work with operations to resolve basic compliance discrepancies • Knowledge in Validations and Laboratory area and equipment • Strong 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. • Microsoft 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 optimally interact with all levels throughout the organization. Requirements Education and years of experience; Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.