Associate Quality Application Specialist

The Associate Quality Application Specialist supports the validation, administration, and compliance of quality-related computerized systems in a regulated environment. This role assists with validation documentation, system configuration, and cross-functional coordination to ensure compliance with applicable federal and international regulations. Responsibilities Support compliant validation processes for quality information technology systems in accordance with federal and international regulations. Assist in the preparation, execution, and maintenance of validation documentation, including SOPs, protocols, and reports. Coordinate validation activities with Quality, IT, Engineering, and business users, including domestic and global stakeholders as applicable. Identify current and anticipated requirements for compliant computerized operations. Support the implementation and maintenance of procedures, actions, and documentation required to ensure system compliance. Track and report the status of validation activities to support regulatory and audit requirements. Maintain awareness of changing regulatory requirements, audit policies, and validation best practices. Perform system administration and configuration of quality IT applications under guidance. Support continuous improvement initiatives related to quality systems and applications. Perform other duties as assigned. Requirements Minimum Requirements (Must Have) Bachelors degree in Science or Engineering Bilingual: English and Spanish 03 years of exposure to medical, clinical, or regulated environments (academic or professional) Preferred Qualifications (Nice to Have) Knowledge of Six Sigma, CAPA, and Product Non-conformance Exposure to SAP QM Module Experience with TrackWise systems Familiarity with Agile systems and FactoryWorks Knowledge or academic exposure to regulated industries (FDA, GMP, ISO, etc.) *Willing to work 100% On-Site in Juncos, PR.*