QA Specialist

Job Title: QA SpecialistLocation: Louisville, KY 40219Duration: 12 MonthsShift hours: 8AM-5PM (Mon - Fri)Must Have:• Excellent verbal and written communication skills• Experience with electronic Quality Management Systems, with knowledge of GxP such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)• Intermediate-advanced computer skills: Word, Excel, and Outlook (Microsoft Office)Nice To Have:• Italian, Polish, French, German, Portuguese or Spanish level request: intermediate• Pharmaceutical and/or healthcare industry experienceJob SummaryThe NextGen eQMS Implementation Specialist will support the global roll out of a new electronic Quality Management System (QMS), from preparation, through Go-Live and post implementation support "hyper-care". The system will be implemented across multiple business units and countries in the wider clientHealthcare organization. You will be working with a dynamic cross-functional team for the global roll out. The team includes IT, product managers, quality and compliance professionals. You will be a key player in the delivery of this new system.Responsibilities:Liaise between central project team and local team.Responsible for data gathering in preparation for go-live.Responsible for managing training with regional/local teams.Act as Qualified Trainer to support local/regional training.Act as Point of Contact to monitor, report, and escalate user applications issues and ensure these issues are formally logged.Support development of local training (if required).Support development & validation activities of eQMS modules (if required).Adhere to quality standards, policies, and procedures in alignment with regional/local regulatory requirements and industry guidelines.Qualifications:Pharmaceutical and/or healthcare industry experience – PreferredItalian, Polish, French, German, Portuguese or Spanish level request: intermediate - PreferredBachelor's degree or International equivalent in Science related field – PreferredExperience with electronic Quality Management Systems, with knowledge of GxP such as Good ManufacturingPractice (GMP), Good Distribution Practice (GDP)Intermediate-advanced computer skills: Word, Excel, and Outlook (Microsoft Office)Excellent verbal and written communication skillsAbility to work in a fast-paced environment