Quality Assurance Auditor

Sunrise, FL 33309

Posted: 08/19/2019 Industry: Biotech Job Number: 236774 Pay Rate: 75000 - 75000

Position Summary:

Monitors and reports results of the Quality Management System compliance of the company and in providing guidance for the organization team on matters relating to compliance. As a quality auditor this position performs periodic documented examination and verification of activities, records and processes of quality system from all the regulatory bodies associated with the company, in order to determine the effectiveness and dependability of such system. As an auditor he/she monitors all quality standards for the manufacturing activities and support activities.

Key Accountabilities:

Maintains, and revises policies and procedures for the general operation of the Quality Management Systems compliance program and its related activities to prevent non-conformances.

Manages day-to-day operation of the program including internal and external audits.

Collaborates with other departments (e.G., Research and Development, Manufacturing, Operations, Purchasing, Quality, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with other members of the team as needed to resolve difficult compliance issues.

Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated and resolved.

Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.

Identifies potential areas of compliance vulnerability and risk; propose the necessary corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.

Monitors the performance of the Quality Management System compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.

40% or more travel expected

Malani Schoenwetter

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