Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility.
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.