Implementing estimating software to clients and training personnel on estimating software.

Kept employees within a GMP facility up to dates and compliant with regulations such as cGMP, FDA, EU, OSHA, and HIPAA. Maintaining training records and establishing training and curriculum requirements for departments.Coordinated and facilitated trainings to keep up to date with regulations.Performed software configurations with eQMS software (MasterControl), LabVantage LIMS, as well as Trakcel Clinical Trial Management Software.Assessed training needs for electronic systems and softwares used within both operations and quality systems.Authored Work Instructions to capture the operation of computerized management systems within a GMP Facility.Developed and authored an array of training material using Articulate Software.Performed demonstrations on softwares (MasterControl,, quality systems (CAPA, NC, and Change Controls), supply chain workflows (Updated regulations for receipt of products), for SME's and department functions as well.Coordinated with software vendors for research into bug fixes and help implement installations.Designated user roles, rights and permissions based on role within the system and configuration matrix within management softwares.Performed duties as a Learning Management (LMS) System Sub Administrator.Developed a site wide curriculum for each department specific to their functions within the company.

Detailed Client needs and ensured documentation for onboarding of a client was completed.Performed and controlled audit calendar for the company. Authored responses for each audit that occured and collaborated with internal departments for responses

Performed IOQ (Installation/Operation Qualification) on equipment within the facility that is used for production.Authored User Manuals and Validation documents for equipment that came into the system.Performed testing and qualification of a new software launch for the Quality Management System (MasterControl).

Performed particles counts with the Climet particle counter to ensure ISO regulations are met within the clean room environment. Conducted growth test using Agar plates to verify no foreign contaminates were discovered in the corridors or clean rooms.