Quality Specialist

Posted:
10/08/18
Type:
Full Time
Location:
Daytona, FL
Category:
Information Technology
Salary:
77,000
Job ID:
101428

An awesome opportunity!

Ashley Ellis is currently seeking an experienced Quality Specialist for a client in a highly reputable organization. This Quality Specialist will be responsible for the compliance of processes related to Distribution, Post-Market Surveillance and Traceability Quality System Elements. Specifically, this Quality Specialist ensures systems and processes are properly implemented and maintained.

This Quality Specialist will be responsible for:

  • Product disposition process and activities, ensuring compliance to all quality and regulatory requirements
  • QA oversight of distribution process, product shipping, traceability, and containment
  • Evaluating and implementing system and process improvements
  • Implementing operating procedures and centralized processes and templates
  • Analyzing metrics and informatics to monitor the Quality System and its compliance
  • Serving as a key quality systems expert to functional business units and Quality Operations
  • Traveling to any company facility or vendor facility, when necessary
  • Keeping abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements

 

This Quality Specialist should have:

  • Bachelor’s Degree in Engineering
  • 4+ years of professional experience and with FDA, cGMPs and other regulatory requirements
  • Experience with ISO, GxP, USP & ICH
  • Knowledge of CAPA, Risk Management and root-cause investigation
  • Exceptional problem-solving and verbal/written communication skills

 

This Quality Specialist will enjoy:

  • Working with a stable team of professionals
  • Opportunity to work on a variety of projects
  • Competitive benefits