Quality Auditor in Pharmaceutical/Biotechnology - Remote

Overview

This role involves independently organizing and performing quality audits under general direction to ensure compliance with Pharmaceutical/Biotechnology industry quality standards.

In Short

• Independently conducts quality audits of suppliers, third parties, and internal manufacturing sites.
• Participates in Pre-Approval Mock Inspections for regulatory readiness.
• Provides cGMP guidance for continuous improvement projects.
• Assists in evaluating metrics for identifying improvement opportunities.
• Supports regulatory agency inspections and external audits.
• Possesses technical knowledge in various areas including API and Sterile Drug Products.

Requirements

• Experience in conducting internal and external audits.
• Technical knowledge of Pharmaceutical/Biotechnology standards.
• Ability to prepare and communicate audit reports effectively.
• Supports the audit program and contributes to audit planning.
• Tracks audit responses and corrective actions.
• Expands technical knowledge as a lead auditor.

Benefits

• Commitment to equal employment opportunity.
• Supportive work environment focused on collaboration.