Full-Time Senior Auditor Enterprise Quality Auditing

• Participates in Pre-Approval Mock Inspections to prepare internal & CMO facilities for regulatory inspections and assesses gaps in the quality systems and overall infrastructure.
• Provides cGMP guidance for continuous improvement projects to ensure compliance with regulations and current industry standards.
• Assists in the evaluation of metrics to determine trends and opportunities for continuous improvements.
• Provides support during regulatory agency and external third party inspections.
• Possesses sound technical knowledge and auditing experience in multiple areas, such as API, Analytical Laboratories, Sterile Drug Product, Contract Packaging, Mock PAI, etc.

• Experience in conducting internal and external audits.
• Technical knowledge in Pharmaceutical/Biotechnology industry standards.
• Ability to prepare audit reports and communicate findings effectively.

• Supports the audit program by independently conducting audits or participating as an audit team member.
• Contributes to the development of the annual audit plans and schedules.
• Schedules audit activities and provides audit agenda.
• Tracks audit responses and auditee’s CAPAs through completion and closeout.
• Expands technical knowledge and auditing experience as lead auditor across the range of branded product suppliers.
• Supports collection and collating of applicable key auditing performance parameters in contribution of reporting metrics.

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