Responsibilities may also include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, product/raw material sampling and/or testing, sampling/testing/data analysis of environmental monitoring samples and data, auditing, data analysis for stability, etc.