Quality Application Specialist

Medial Group; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, seeks a qualified professional to lead validation of quality information technology systems in a regulated environment. The role requires formal documentation, SOPs, and coordination with clients, developers, and site personnel.

Desirable candidates have 5+ years in the regulated industry, experience with Process Validation and Computer System Validation, and a background in Medical Devices regulatory affairs. On-site work in Juncos, PR is required.

Qualifications

• Minimum 5 years of experience in the regulated industry.
• Experience in Process Validation and Computer System Validation.
• Experience in Medical Devices Regulatory and Technical background.
• Bachelor Degree in Science or Engineering completed.
• Bilingual.

Responsibilities

• Conducts a compliant validation process for quality information technology systems with formal validation documentation.
• Coordinates activities with clients, programmers/developers and operating personnel, domestically and globally as appropriate.
• Identifies requirements for compliant computerized operations and suggests methods for implementation and maintenance of procedures and documentation.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements and audit policies.
• Performs system administration and configuration of quality information technology systems.
• Performs other duties as assigned.

Skills

Process Validation

Computer System Validation

Regulatory Knowledge

Bilingual

Education

Bachelor Degree in Science or Engineering

Job description

Juncos, Puerto Rico | Posted on 04/11/2025

• Industry Pharma/Biotech/Clinical Research
• City Juncos

Job Description

Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques. Performs system administration and configuration of quality information technology systems. Perform other duties assigned.

Requirements

Minimum 5 years of experience in the regulated industry. Experience in with Process Validation and Computer System Validation. Experience in Medical Devices Regulatory and Technical background. Bachelor Degree in Science or Engineering completed. Bilingual. Willing to work 100% On-site in Juncos, PR.