Job Description

Quality Compliance Auditor

The purpose of this position is to conduct and manage Quality Assurance External and Internal GMP Audits and to assure compliance with the GXP Audit Program.  The audits will be primarily focused on current Good Manufacturing Practices (GMP) but may include conformance to ISO standards where implemented.  The position will also be responsible for managing Quality Agreements and the Supplier/Vendor Qualification Program.

RESPONSIBILITIES 

• Maintain GXP audit program for external supplier audits.
• Perform GXP external audits per Client's annual Master Audit Schedule.
• Prepare GXP external audit reports with details on audit scope and observations of non-compliance.
• Assist with regulatory inspections and partner audits.
• Conduct annual Mock Recall for commercial products.
• Create and author Standard Operating Procedures (SOPs) as needed to support GXP external audits.
• Recommend corrective and preventive actions as need to support compliance within the department.
• Manage and maintain the Quality Agreements.
• Manage and maintain the Supplier/Vendor Qualification Program
• Other duties as assigned.
• The position requires approximately 30% travel consisting of both domestic and international

QUALIFICATIONS

• Relevant GMP Quality audit experience.
• Strong knowledge of US and EU GMPs and their application.
• Working knowledge of GCP and GLP regulations and requirements.
• Ability to use Microsoft Word and Excel applications.
• Ability to work proactively and cooperatively with managers and operational staff to solve quality problems.
• Ability to manage multiple responsibilities with a high degree of self motivation.
• Good written, oral and interpersonal English communication skills.
• Understanding of Quality Agreements.
• Knowledge of Supplier/Vendor compliance.

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Company Description

Investment Management Company