Quality Assurance Specialist

Position Title : Quality Assurance Specialist

Location : North Chicago, Illinois, 60064

Assignment Duration : 6 months (possible extension)

Work Schedule : First shift, with overtime offered

Work Arrangement : Onsite laboratory role

Position Summary

The Quality Assurance (QA) Specialist will work within the Operations Quality Assurance organization, focusing on investigating return samples for medical device and combination product complaints and inquiries.

Key Responsibilities

• Operate in a laboratory environment, utilizing Personal Protective Equipment (e.g., gloves, lab coat, safety glasses).
• Perform product complaint documentation, investigation, and review of non-medical complaint content.
• Review complaints involving non-medical quality issues, ensuring compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).
• Ensure complaint data meets all regulatory requirements.
• Safely handle sharps (e.g., needles) that may be potentially biohazardous.
• Identify potential reportable events and notify appropriate functional groups and management.
• Review documents and propose changes to support team objectives.
• Manage time effectively with minimal supervision, proactively carrying out tasks and suggesting process improvements.
• Take initiative as a key contributor to team activities.
• Complete special projects in resourceful and effective ways to meet group needs.

Qualifications & Experience