Consistently ranked as a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies, our client offers a unique, world-class opportunity for interested candidates. An outstanding Senior GMP Auditor is required who is excited by a start-up environment and recognizes the opportunities that this offers and wants to be challenged

Summary:Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.

Responsibilities

• Schedules, prepares, and conducts audits in support of GMP as directed.
• Assembles and coordinates the activities of the audit team.
• Conducts audits in accordance with standard operating procedures and quality policies.
• Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
• Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
• Escalates any compliance issues.
• Communicates audit results to management and auditees through written audit reports.
• Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
• Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
• Drafts and issues periodic reports to site management as requested.
• Assists with training/orientation for new Quality Auditing staff.
• Supervises junior auditors.

• BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry
• 2-5 years of audit experience in GMP environment