Senior Qa Specialist
Current-Pioneer the implementation and utilization of LabVantage software in the Quality Assurance role. Conducted training sessions for staff, focusing on essential features, updates, and compliance requirements to ensure proficiency and adherence to industry standards.-Perform compliance review of the following records: master batch records, executed batch records, and internal support records (to include logbooks as needed). Support management with the generation of metrics, as needed.-Perform compliance review on laboratory investigation reports (LIR) from initial investigation to full investigation.-Work directly with manufacturing, and other internal departments to support resolution of client comments in a timely manner in support of batch release activities and Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities. Communicates directly with clients to resolve issues related to batch disposition.-Support process improvement projects to include improving the lifecycle of batch record review cycle times and batch release dates.-Attend relevant operational meetings in support of QA batch records and disposition activities, as determined by Supervisor.-Able to react to change productively and handle other essential tasks as assigned.
