Associate Quality Application Specialist

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

Associate Quality Application Specialist

Juncos, Puerto Rico | Posted on 12/29/2025

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.*