Associate Quality Application Specialist

Mg Staffing Group

19h • Onsite

About The Position

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.

Requirements

• 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)

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level