QA Lead Auditor

Responsibilities

• Able to perform high-profile audits for manufacturing facilities and clinical trial sites
• Lead a team of auditors, conduct manufacturing sites audits, and identify and follow up on any resolved audit findings identified during a Quality Assurance Audit
• Adheres to all safety, environmental, and quality requirements, not limited to: Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
• Schedules audit activities with the internal sites and provide audit agenda
• Writes audit reports of findings, recommendations, and management corrective action plans
• Assures that issues from sponsor audits are promptly communicated to the appropriate team
• Tracks audit responses and auditees' remediation CAPAs until completion and closeout
• Independently performs evaluations of quality systems and practices to identify potential problems
• Stays up to date on current FDA and Health Canada manufacturing trends

Requirements

• Previous work experience with FDA or Health Canada Agencies is a requirement
• Minimum of a BS degree in science with a minimum of 5+ years of experience in performing and discussing audits
• Thorough knowledge of current standard practice and regulations
• Ability to review technical documents