Quality Application Specialist

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.