Job Description

Job Responsibilities

Internal Audits

• Plans and conducts assigned audits.
• Performs For Cause audits.
• Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.

Customer Audits/Inspections

• Prepares for and hosts or supports customer audits.
• Prepares for and hosts or supports Regulatory Authority Inspections.

Other Responsibilities

• Serves as Lead Auditor on team-based internal audits.
• Serves as a trainer and mentor to less experienced QA auditors.

Supervision

• Requires minimal instructions on day-to-day work and new assignments.

Additional Tasks

• May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
• Performs other work-related duties as assigned.
• Moderate travel may be required (up to 50%).

Qualifications

What We’re Looking For

• Bachelor’s degree in a science/healthcare field or equivalent with extensive experience in GxP quality assurance auditing.
• Previous experience in conducting multiple audit types (e.g., vendors, investigator sites, trial master files, data management, safety reporting, and laboratories) is preferred.
• Excellent knowledge of GxP regulatory requirements.
• Knowledge of medical and technical terminology related to the audit types to be conducted.
• Computer literacy appropriate to job requirements (Microsoft Office suite; basic SharePoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation, and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse backgrounds.
• Ability to negotiate, problem-solve, and provide constructive feedback.

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