Sr. Quality Applications Specialist
About The Position
Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements. Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs. Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable. Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations. Support and assess documentation and system changes through formal change control and impact assessments. Identify current and future regulatory requirements for computerized systems and recommend strategies to ensure ongoing compliance. Perform system administration and configuration for Quality IT systems (e.g., QMS, CAPA, Document Control, Training, Complaints). Monitor, track, and report validation status to ensure audit and inspection readiness. Stay current with evolving regulatory requirements, audit trends, and industry best practices related to computerized systems and data integrity. Support internal and external audits and regulatory inspections, including preparation and response to findings. Other duties may be assigned
Requirements
- Bachelor’s degree in Engineering completed.
- 4+ years of experience in Quality Systems, Computer System Validation (CSV), or regulated IT environments.
- Strong expertise in Computer System Validation (CSV) lifecycle management.
- Proven experience with quality documentation authoring and review, including validation and SOP documentation.
- Knowledge of FDA, GxP, ISO, and data integrity requirements.
- Experience managing documentation changes and change control processes.
- Demonstrated quality and compliance leadership and ability to influence peers.
- Strong cross-functional communication and stakeholder coordination skills.
Nice To Haves
- Experience in medical device and/or pharmaceutical manufacturing environments.
- Experience supporting global or multi-site quality systems.
- Familiarity with electronic Quality Management Systems (QMS) such as TrackWise, ETQ, MasterControl, or Veeva.
- Experience supporting regulatory audits and inspections related to computerized systems.
- Willing to work 100% on-Site in Juncos, PR.
Responsibilities
- Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements.
- Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs.
- Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable.
- Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations.
- Support and assess documentation and system changes through formal change control and impact assessments.
- Identify current and future regulatory requirements for computerized systems and recommend strategies to ensure ongoing compliance.
- Perform system administration and configuration for Quality IT systems (e.g., QMS, CAPA, Document Control, Training, Complaints).
- Monitor, track, and report validation status to ensure audit and inspection readiness.
- Stay current with evolving regulatory requirements, audit trends, and industry best practices related to computerized systems and data integrity.
- Support internal and external audits and regulatory inspections, including preparation and response to findings.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
