Quality Specialist

CONFLUX SYSTEMS
Louisville, KY

Here are the job details for your review:

Job Title: Quality Associate

Location: LOUISVILLE Kentucky 40219

Duration: 10 Months

Pay rate: 40.00/hr. W2

Shift Hours: 1st Shift | 7:00am - 3:30pm [MON-FRI]



Job Summary

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 UPS 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.

Qualifications:

  • 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
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