Quality Systems Specialist - III

Quality Systems Specialist III

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). Independently conduct, complete, and document critical, major, and minor investigations related to GxP operations. Facilitate cross-functional meetings with internal and external parties as required. Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions. Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets. Responsible for maintaining tracking tools/databases. Responsible for sending periodic reminder notifications to leads/coordinators. Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required. Supports the maintenance and improvement to quality systems processes, as needed Works directly with operating entities and internal clients to ensure follow-up of quality issues. Participate in the development of training programs regarding all aspects of producing quality products, as required. Assist compliance audits as required. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.