Job Description

Job Description

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)

  • Bachelor’s degree in Science or Engineering

  • Bilingual: English and Spanish

  • 0–3 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.*



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