Lanelle Dort

Background

About Lanelle Dort

My experience includes managing and expediting the development and approval of validation and commissioning protocols for various equipment on an accelerated schedule to support product release. In addition, I have been responsible for managing pharmaceutical complaints, investigations, CAPA's and Change Controls. As a Sr QA Specialist, I have successfully directed others, established clear direction and set stretching objectives. In this role, my planning skills were displayed by accurately scoping out the length and difficulty of tasks and projects; developing schedules and tasks/people assignments; maintained two-way dialogue with others on work and results; and anticipated/adjusted to problems and roadblocks. As a QS Compliance Specialist I established a TRB (Technical Review Board) to monitor and support the completion CAPAs, Deviations, and Product Complaints in order to meet target dates. In addition, I was responsible for authoring the Annual Product Reviews and compiling data for the MCSRs. I also managed the Quality management system which includes logbooks, batch records, assay forms, and SOP and protocol templates. Daily responsibilities included formatting and editing controlled documents that support GMP operations and comply with cGMP and FDA guidelines. My background includes IQ, OQ, PQ, Cleaning Validation and Process Equipment Validation, execution, review and summary report generation. Familiar in the requirements of ISO 14971 Risk Management standard and completed and passed the evaluation for ISO Lead Auditor Course with Emphasis on ISO 13485:2003.