As a Quality Systems Specialist working for a contract pharmaceutical company I procure relevant information to develop an investigation and ensure my reports are aligned with regulatory requirements, standard operating procedures (SOPs) and company policies.  I am required to review protocols, analytical results and documentation associated with investigations to ensure their compliance with regulations for the quality of the investigations, the identification of the root cause, the identification of the appropriate corrective and preventative actions, and assessment of the product impact.  Additionally, I assist with the development of CAPAs and collaborate with stakeholders to ensure that all necessary activities are executed in a timely and effective manner.   When necessary, I interface with contract customer representatives to notify the affected parties of process or product exceptions and determine responsibilities and solutions related to an observed event.  I support both domestic and international regulatory inspections, assist in their preparation, and identify corrective actions as needed.