What are the responsibilities and job description for the QA Specialist position at eTeam?
Job Title: QA Specialist
Location: Louisville, KY 40219
Duration: 12 Months
Shift 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 experience
The 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 client
Healthcare 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.
- Pharmaceutical and/or healthcare industry experience - Preferred
- Italian, Polish, French, German, Portuguese or Spanish level request: intermediate - Preferred
- Bachelor's degree or International equivalent in Science related field - Preferred
- 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)
- Excellent verbal and written communication skills
- Ability to work in a fast-paced environment
Salary : $30 - $34