QA Specialist: Change Control & CSV in Pharma

Veg Group; Aguadilla (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Job summary

Validation & Engineering Group, Inc. is seeking a Quality Assurance Specialist to provide independent QA oversight for Change Control, Qualification, and CSV activities within a GMP-regulated environment. The ideal candidate has 3+ years of QA experience in life sciences, strong documentation practices, risk-based thinking, and the ability to communicate findings clearly in English. Spanish proficiency is preferred for site interaction.

Qualifications

• 3+ years QA experience in GMP-regulated life-sciences environments.
• Experience reviewing Change Control, Qualification/CSV records and closure.
• Knowledge of GMP, GDP, data integrity, 21 CFR Part 11, and related standards.

Responsibilities

• Provide independent QA oversight for Change Control, Qualification, and CSV activities.
• Review records for completeness, risk, traceability, and compliance.
• Escalate significant quality or schedule risks to management.
• Coordinate cross-functional meetings and track actions.
• Approve or reject records within delegated authority.

Skills

QA oversight

GMP compliance

Change Control

CSV

Documentation

Regulatory knowledge

Risk assessment

English communication

Education

Bachelor degree in science/engineering/quality

Tools

eQMS

Electronic approvals

Job description

Validation & Engineering Group, Inc. is seeking a Quality Assurance Specialist to provide independent QA oversight for Change Control, Qualification, and CSV activities within a GMP-regulated environment. The ideal candidate has 3+ years of QA experience in life sciences, strong documentation practices, risk-based thinking, and the ability to communicate findings clearly in English. Spanish proficiency is preferred for site interaction.