Product Complaint Analyst I

Actalent - North Chicago, IL

Full-time - Entry Level

Hybrid - North Chicago, IL

10,001+ employees

Administrative and Support Services

About the position

The Product Complaint Analyst I will be part of a global quality organization, focusing on processing complaints and inquiries related to pharmaceutical, medical device, and combination products. The role involves interfacing with various internal and external stakeholders to ensure proper documentation and investigation of product complaints, as well as identifying potential adverse events. Responsibilities also include regulatory reporting and customer communication.

Responsibilities

• Process pharmaceutical, medical device, and combination product complaints and inquiries.
• Interface with internal customers such as physicians, nurses, and pharmacists regarding product complaints.
• Document product complaints and conduct investigations to identify potential adverse events.
• Create and submit regulatory reports as required.
• Develop customer communications related to product complaints.
• Collaborate with third parties as necessary.

Requirements

• Experience in GxP (Good Practice) environments.
• Knowledge of Quality Assurance (QA) processes in healthcare.
• Strong analytical skills for evaluating product complaints.
• Technical writing skills for creating reports and documentation.
• Good documentation practices to ensure compliance.

Nice-to-haves

• Experience in the pharmaceutical or medical device industry.
• Familiarity with regulatory requirements for product complaints.

Benefits

• Flexible work environment with hybrid options.
• Opportunity to work with a global leader in engineering and sciences services.