Qa Specialist Ii
CurrentDeveloped a QMS from the ground up, catered towards clinical trial services, clinical diagnostic services and research developments. Primary responsibilities include;• Equipment Management; development of processes for equipment procurement and retirement, equipment qualification and validation, logical security and data governance. Creation of all Standard Operating Procedures for various levels of equipment. • Document Management Processes; improved organization of documents and implemented controlled processes for creating, managing and accessing documents. • Incident Management; implemented a flexible system for reporting, assessing and tracking of non-conforming events. Oversee all risk assessments and corrective actions. • Day-to-day activities include overseeing Equipment Management procedures such as Validation / Verification and Access Control and Document Management, such as annual review of documents, regular gap analysis, formatting, review and publishing of controlled documents.• Actively provide training to established and new employees over quality principles• Quarterly assessments with leadership to establish quality initiatives and quality objectives.
