Job Description

SUMMARY

Seeking a QA Specialist for a short-term hybrid assignment focused on validation document review. The role involves ensuring calibration and validation records are accurate, compliant, and meet quality standards. This position is ideal for someone with QA/Validation expertise who can quickly adapt and deliver results in a dynamic environment.

RESPONSIBILITIES

• Review and evaluate validation documentation, with emphasis on identifying Out of Tolerance (OOT) issues.
• Conduct review of calibration and validation documents to ensure compliance with quality standards.
• Audit calibration records, interpret results, and confirm regulatory compliance.
• Maintain and update documentation through a computer-based QA/validation system.
• Track issues, document findings, and generate reports for quality leadership.
• Collaborate with QA leadership to resolve discrepancies and support process improvements.

QUALIFICATIONS

• Proven experience in quality assurance within the pharmaceutical or life sciences industry.
• Hands-on background in reviewing calibration and validation documentation.
• Strong computer skills, including use of computerized QA/validation systems.
• Detail-oriented with ability to identify OOT gaps and documentation inconsistencies.
• Ability to adapt quickly and manage short-term project-based assignments.

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