QA Specialist: Change Control & CSV in Life Sciences

Pinnaql, Inc.; Guaynabo (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

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

The role involves evaluating records for completeness, risk, and data integrity, and escalating issues to management as needed. Responsibilities include coordinating cross-functional meetings, leading the Change Control Committee, and ensuring proper documentation and approvals.

Qualifications

• At least three years QA experience in GMP-regulated pharma/biotech/life-sciences.
• Experience with Change Control and CSV activities.
• Reviewing Change Control records through closure.
• Reviewing qualification/CSV lifecycle documents and protocols.
• Knowledge of GMP, GDP, data integrity, FDA cGMP and 21 CFR Part 11.
• Strong English; Spanish preferred for site interaction.
• Prioritize multiple Change Control, Qualification, CSV tasks.

Responsibilities

• Provide independent QA oversight for Change Control, Qualification, and CSV.
• Evaluate records for completeness, risk, traceability, and compliance.
• Identify compliance risks and escalate to management as needed.
• Coordinate cross-functional meetings and track actions.
• Lead Change Control Committee and document decisions.
• Ensure timely approvals and proper documentation in systems.

Skills

Quality Assurance

Change Control

CSV Validation

GMP GDP

Cross-functional coordination

English proficiency

Education

Bachelors in science/engineering

Equivalent education/experience

Tools

EQMS

Validation software

Job description

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

The role involves evaluating records for completeness, risk, and data integrity, and escalating issues to management as needed. Responsibilities include coordinating cross-functional meetings, leading the Change Control Committee, and ensuring proper documentation and approvals.