What are the responsibilities and job description for the Senior Specialist, Quality Systems position at Innova?
Seeking a Senior Specialist, Quality Systems to provide quality expertise to support our Quality’s team for the development and commercialization of our products in compliance with relevant US, EU and ICH requirements. Support in the execution, development, & continuous improvement of the Document Control / Management & Training Program as we grow & mature organizationally. We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (eQMS), & to implement process improvements to meet business & regulatory requirementsResponsibilitiesSupports the day-to-day management of the Quality Systems department, including areas such as Document Control & Training.Assist with the development & implementation of controlled documents including, but not limited to : SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.Maintain internal formatting standards & ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering & any other activities required to achieve document requirements.Assist with Quality training program.Collaborate with department managers to develop training requirements & training plans.Create & maintain GxP training files & matrices.Participate in system validation activities, as required.Generate compliance metrics & prepare KPI reports.Assists in delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS.Plus more...
