product complaint analyst i

$49,920 - $57,533/Yr

Randstad - Waukegan, IL

Full-time - Entry Level

Waukegan, IL

Administrative and Support Services

About the position

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.

Responsibilities

• Assure complaint records meet global requirements.
• Document, investigate, and review all non-medical complaint content.
• Review medical complaints that involve a non-medical quality related problem.
• Provide quality customer service through coordination of return samples for investigation and follow-up activities such as product replacement.
• Ensure that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
• Ensure complaint files meet all regulatory requirements.
• Identify potentially reportable events and notify appropriate functional groups and management.
• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, and regulatory agencies.

Requirements

• A Bachelor Degree required, preferably in technology or scientific background (MLT, LPN, RN).
• 1-3 years' work experience in a cGMP related industry or in a clinical setting is preferred.
• Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

Benefits

• Health insurance coverage
• 401K contribution
• Incentive and recognition program