Randstad - Waukegan, IL
posted about 2 months ago
As a Product Complaint Analyst I, you will play a crucial role in ensuring that product complaint records meet global regulatory requirements. This position is integral to the quality assurance process within a leading biopharmaceutical company known for its innovative treatments for difficult-to-cure diseases. You will be responsible for the documentation, investigation, and review of all non-medical complaint content, as well as overseeing medical complaints that involve non-medical quality-related issues. Your work will involve providing quality customer service through the coordination of return samples for investigation and follow-up activities, such as product replacement. In this role, you will ensure that all complaint documentation adheres to Good Documentation Practices, as well as Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). This requires strong analytical skills, technical writing abilities, and meticulous attention to detail to ensure that complaint files meet all regulatory requirements. You will also be tasked with identifying potentially reportable events and notifying the appropriate functional groups and management. Collaboration is key in this position, as you will interface with Third Party Manufacturers, healthcare professionals, the general public, internal customers, and regulatory agencies. Your ability to communicate effectively and work with cross-functional teams will be essential to your success in this role.