QA Product Complaint Analyst

$56,160 - $56,160/Yr

Orion System - Waukegan, IL

Full-time - Entry Level

Waukegan, IL

Professional, Scientific, and Technical Services

About the position

The QA Product Complaint Analyst role involves processing pharmaceutical, medical device, and combination product complaints and inquiries within a global quality organization. The position requires documentation, investigation, and review of product complaints, ensuring compliance with regulatory standards and providing quality customer service. This is a temporary contract position with a hybrid work schedule after training.

Responsibilities

• Interface with internal customers such as physicians, nurses, pharmacists, and hospital personnel regarding product complaints.
• Document product complaints and conduct investigations to identify potential adverse events.
• Create and submit regulatory reports and customer communications.
• Ensure complaint records meet global requirements and Good Documentation Practices.
• Review medical complaints related to non-medical quality issues.
• Coordinate return samples for investigation and follow-up activities, such as product replacement.
• Identify potentially reportable events and notify appropriate functional groups.

Requirements

• Bachelor's degree required, preferably in technology or a scientific background (MLT, LPN, RN).
• 0-3 years of work experience in a cGMP related industry or clinical setting preferred.
• Knowledge of global regulatory requirements for pharmaceutical and medical devices.
• Familiarity with FDA requirements for Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, and 211).
• Solid written and verbal communication skills.
• Experience with Microsoft Excel (sorting, filtering) for at least 3 years.
• Experience in quality or complaint handling for at least 2 years.

Nice-to-haves

• Knowledge of complaint management computer systems.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
• Experience working with cross-functional teams.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Vision insurance