Quality Specialist – Cataño

Perform physical inspection of products and comparison to all documentation as needed (certificate or analysis, packing list, bill of lading, temp tale management, etc.). Initiate procedure revisions as needed to support continuous improvement. Manage the state licensure program to ensure no licenses expire. Manage the document retention program. Support assigned responsibilities for document tracking and overall facility documentation control. Manage monthly data trends. Perform Internal Assessments to ensure continuous improvement. Process product hold requests ensuring all product is quarantined. Perform manual product releases after verification of release by manufacturing plant in Batch Release System (BRS) as necessary.
Requisitos:
AS or BS in Science, Metrology, Pharmacy with 2-4 years of Quality experience with problem solving. Pharmacy Technician Certificate preferred. Demonstrated understanding of quality assurance in an FDA-regulated environment. Familiarity with auditing techniques, regulations and quality systems. Strong computer skills Microsoft Office. Excellent communication skills (i.e. both oral and written) in Spanish and English. Ability to interpret changes, manage a number of ongoing projects and meet deadlines. Work with minimal supervision. Must be able to demonstrate an attitude of integrity, trust, work ethic, accountability, collaboration, teamwork, and customer focus. (Temporary position-six months 25662)