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Compliance Associate

3 months ago

Billerica, United States ProStaff Workforce Solutions Full time

Full-time Onsite

Contract

Job Summary:

The Temporary- Associate Compliance provides support in the evaluation and investigation of product quality complaints. Ensures compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and Quality Management System Standard Operating Procedures related to product complaint handling.

Area Of Responsibility

  • Support and assist the QA Complaint Coordinator and the QA Compliance Head on the evaluation and investigation of product quality complaints.
  • Work directly on technical investigations relating to Product Quality Complaints.
  • Document the evaluation and investigation of Product Quality Complaints within the Trackwise system.
  • Other duties as assigned


Qualifications

  • BS in a scientific field a plus
  • Minimum 2-4 years related experience in a pharmaceutical/medical device manufacturing regulated environment
  • Working knowledge of cGMPs (current Good Manufacturing Practices) and GDP’s (Good Documentation Practices)
  • Strong working knowledge of MS Word software
  • Must have exceptional writing skills to document the evaluation and investigation processes completed.
  • Experience evaluating and investigating drug/device product complaints
  • Experience using Trackwise, Veeva or QMS
  • Superior internal customer service/people skills
  • Ability to manage multiple responsibilities in a fast-paced environment, while performing in an efficient manner