Title:  TEMP Associate Compliance

ob 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

Work Conditions:

• Office

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms,
• Talk and hear
• Close vision
• Computer/office machines
• Lift up to 10 lbs.

Travel Estimate

• 0%

Education and Job Qualification

• BS in a scientific field a plus
• Superior internal customer service/people skills
• Ability to manage multiple responsibilities in a fast-paced environment, while performing in an efficient manner

Experience

• Minimum 3 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 a plus
• Experience using the Trackwise complaint module a plus