QA System Validation Specialist

QA System Validation Specialist

Summary

We are seeking a QA System Validation Specialist to manage and execute validation activities that ensure healthcare systems comply with regulatory standards. This role focuses on maintaining validation documentation, supporting audits, and collaborating with IT and Engineering teams to uphold system integrity under 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.

Responsibilities

• Manage and maintain validation programs for the healthcare warehouse and support systems.
• Write, review, and approve validation documentation including plans, URS, FRS, IQ / OQ / PQ protocols, and reports.
• Review and assess change control requests to evaluate their impact on validation status.
• Conduct audit trail reviews, validation evaluations, and prepare system status reports.
• Partner with IT, Engineering, and Operations teams to identify and validate systems used in healthcare operations.
• Support internal and external audits by ensuring documentation accuracy and regulatory readiness.
• Investigate deviations, document findings, and support CAPA implementation.
• Provide regular validation project updates, tracking milestones and communicating progress to stakeholders.

Requirements

This is a 6-month Contract opportunity with our Alpharetta, GA client. Employee benefits include Medical / Dental Benefits, Paid time off, Paid Holidays, and 401(k). H1-B Visa sponsorship is not available for this position.

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