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Quality Compliance Supervisor - Aibonito
Ensures compliance with Quality and Manufacturing Processes. Supervises internal audits activities, and activities related to various processes and Certifications. Responsible to ensure areas are prepared for regulatory inspection. Maintains the on-time data gathering for the site Key Performance Indicators (KPIs) and their submission on time for Management Review presentation. Identifies preventive actions and improvement activities. Oversight of Internal Audits (including corrective actions, preventive actions, effectiveness checks, and Observation Certification Program). Performs the Annual Product Quality Report final reports. Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies. Review changes in specifications and SOPs under CDR system. Support/manage non-conformance investigations (NCR, CAPA, etc.) and Internal Audits’ NCRs.
Requisitos: Requirements: Bachelor's degree in Science or Engineering with experience in Quality Assurance, Quality Control or Documentation. At least 5 years of experience in Quality in a Medical Devices regulated industry, or similar. Excellent communication skills in Spanish and English. Knowledge in Statistics preferred. Computer software knowledge (Microsoft Office and others). Must be able to observe confidentiality and data privacy rules. Con Alguna Experiencia Requires Intermediate Experience Beneficios: Benefits Package: Compensation will be determined based on the educational qualifications and experience of the selected candidate. LabChemS Corp (LCC) is a leading company in consulting services, laboratories and support resources, primarily for the medical and pharmaceutical device industries in Puerto Rico and Costa Rica.
Empleos en Puerto RicoJobs in Puerto Rico
LabChemS Corp.
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