Plan, conduct and document audits of entities participating in nonclinical studies and the manufacturing, testing, fill/finish and storage/distribution of materials utilized in activities managed by Emergent.
They will work with the team to integrate plans for Quality Assurance, Project and Risk Management, Testing, Training, Release, and others ensuring that all non-conformances are tracked to resolution, and certifying that products and processes are ready for delivery prior to release.
Conduct trending analysis on issues identified in the corrective action program and enhance communications by performing as a liaison function between all command departments. Support the development or revision of QM manuals and procedures in accordance with current regulatory and administrative requirements.
Responsible for auditing internal and external-utilizing a risk based strategy. Support and provide advice to a number of functional areas including manufacturing, facilities, IT and other Quality departments.