Quality IT Validation Specialist – On-Site (Juncos, PR)

Medial Group; Juncos (PR); On-site; USD 50,000 - 70,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, is seeking an Associate Quality Application Specialist to support validation, administration, and compliance of quality IT systems in a regulated environment. The role involves preparing validation documents, configuring systems, and coordinating with Quality, IT, and business users to maintain compliance.

The ideal candidate will have a science/engineering degree, bilingual English and Spanish, and 0–3 years exposure to regulated settings.

Qualifications

• Bachelor's degree in Science or Engineering is required.
• Exposure to regulated environments (FDA, GMP, ISO) is preferred.
• Bilingual English and Spanish is required.

Responsibilities

• Support compliant validation processes for quality IT systems.
• Assist in preparation, execution and maintenance of validation documentation (SOPs, protocols, reports).
• Coordinate validation activities with Quality, IT, Engineering and business users.
• Identify requirements for compliant computerized operations.
• Support procedures and documentation to ensure system compliance.
• Track and report the status of validation activities for regulatory/audit needs.
• Maintain awareness of changing regulatory requirements and audit policies.
• Perform system administration and configuration of quality IT applications.

Skills

Bilingual English/Spanish

Regulatory awareness

Cross-functional coordination

Documentation & SOPs

Validation processes

Education

Bachelor's degree in Science or Engineering

Tools

SAP QM Module

TrackWise

Agile systems

FactoryWorks

Job description

Medial Group in Juncos, Puerto Rico, is seeking an Associate Quality Application Specialist to support validation, administration, and compliance of quality IT systems in a regulated environment. The role involves preparing validation documents, configuring systems, and coordinating with Quality, IT, and business users to maintain compliance.

The ideal candidate will have a science/engineering degree, bilingual English and Spanish, and 0–3 years exposure to regulated settings.