Quality / Compliance Auditor

Position : Quality / Compliance Auditor

Location : Los Angeles, CA

Duration : 12 Months Contract

Job Description :

This position entails performing routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, providing compliance guidance and support throughout the Quality organization, training delivery, and leading multi-departmental teams and initiatives. To ensure success as a Quality Auditor, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and / or cGxP auditing and demonstrated project management experience in leading cross-functional teams.

Key Responsiblities :

• To ensure success as a Quality Auditor, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or cGxP auditing and demonstrated project management experience in leading cross-functional teams.
• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assisting in implementing Internal Audit plans for all Client manufacturing plants.
• Assisting in implementing Supplier Audit plans for all Client manufacturing plants.
• Trends, analyses, and reports on quality data to improve product and process Quality for all Client plants; develop actions for improvement based on data analyses.
• Peer Review of Audits Reports.
• Provide support prior, during and post inspections for external Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keeping abreast of industry standards and regulations.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
• Contribution to the continuous improvement of the Quality Management System is required.
• Other additional duties may be assigned by the Director Quality Audits from time to time if required. Ability to travel (up to 30%)

Skills :

Abilities :

Ability to travel. (up to 30%)

Ability to generate and / or maintain reports, databases and presentations using Microsoft Office.

Flexible, able to adapt quickly to change in a fast-paced environment.

Qualifications :

Desirable : Experience in SAP

TB_PH