Senior Quality Assurance Specialist
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About The Position
We are seeking a Contract Quality Assurance (QA) Sr. Specialist to support deviation investigations related to Good Manufacturing Practice (GMP) operations at our state-of-the-art lentiviral vector development and manufacturing facility in Louisville, CO. This position is crucial for ensuring compliance with regulatory standards and maintaining the integrity of our manufacturing processes. The Sr. QA Specialist will be responsible for the independent triage of potential non-conforming events, assessing immediate corrections, and determining the need for subsequent deviations while assigning criticality in alignment with established procedures. The role involves the identification and assembly of cross-functional teams to achieve defined investigation milestones. The specialist will utilize appropriate root cause analysis tools that correspond with the complexity and criticality of the investigations. Execution and management of investigations will be conducted within the electronic Quality Management System (eQMS), ensuring adherence to defined requirements. The Sr. Specialist will also manage timelines for deviation corrections, corrective actions, and preventive actions, while proactively communicating and escalating risks associated with investigations. In addition to providing updates to site management and participating in cross-functional business reviews, the Sr. QA Specialist will contribute to the establishment of deviation program metrics and continuous improvement initiatives. There is potential for mentoring and training investigators, assisting in the development of investigation training materials, and cross-training within the Quality Assurance organization to provide oversight and support across other GxP tasks and programs. The role may also involve supporting QC laboratory investigations and other duties as assigned.
