QA & CSV Specialist — Change Control Leader

Veg Group; Guaynabo (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Assurance Specialist to provide independent QA oversight for Change Control, Qualification, and CSV projects in a GMP-regulated environment.

You will review records, assess risk, and ensure traceability, data integrity, and regulatory compliance across lifecycle activities. The role requires strong English communication and cross-functional collaboration, with potential Spanish interaction.

Qualifications

• At least three years in QA within GMP-regulated life sciences environments.
• Experience reviewing Change Control records and CSV lifecycle documents.
• Familiarity with GDP, data integrity, risk-based qualification and validation.
• Knowledge of FDA cGMP, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles.
• Strong written and verbal English; Spanish helpful for site interaction.

Responsibilities

• Provide independent QA oversight for Change Control, Qualification, and CSV activities.
• Review records for completeness, risk, traceability, and compliance; document clear comments.
• Escalate compliance, schedule, or resource risks to management.
• Coordinate QA judgments on approaches to issues and release readiness.
• Monitor and report on change control activities, validations, and related actions.
• Maintain inspection-ready records and dashboards for program status.

Skills

Quality Assurance

Change Control

CSV (Computer System Validation)

GxP Compliance

FDA cGMP

EU GMP Annex 1 & 21 CFR Part 11

Data Integrity

Risk-based Qualification

Cross-functional collaboration

English communication

Education

Bachelor degree in science/engineering/quality or related

Job description

Validation & Engineering Group, Inc. seeks a Quality Assurance Specialist to provide independent QA oversight for Change Control, Qualification, and CSV projects in a GMP-regulated environment.

You will review records, assess risk, and ensure traceability, data integrity, and regulatory compliance across lifecycle activities. The role requires strong English communication and cross-functional collaboration, with potential Spanish interaction.