Product Complaint Analyst / Quality Complaint Analyst

$52,000 - $56,160/Yr

Systems Ally - North Chicago, IL

Full-time - Entry Level

Remote - North Chicago, IL

About the position

The Product Complaint Analyst will work within the global quality organization to process complaints and inquiries related to pharmaceutical, medical devices, and combination products. This role involves interfacing with various internal and external stakeholders to ensure compliance with regulatory requirements and to provide quality customer service. The analyst will be responsible for documentation, investigation, and reporting of product complaints, ensuring adherence to Good Documentation Practices and regulatory standards.

Responsibilities

• Assure complaint records meet global requirements.
• Document, investigate, and review all non-medical complaint content.
• Review medical complaints that involve non-medical quality related problems.
• 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 standards.
• Ensure complaint files meet all regulatory requirements.
• Identify potentially reportable events and notify appropriate functional groups and management.
• Interface with Third Party Manufacturers, healthcare professionals, the general public, internal customers, and regulatory agencies.

Requirements

• Bachelor's degree required, preferably in technology or a scientific background (MLT, LPN, RN).
• 0-3 years' work experience in a cGMP related industry or in a clinical setting 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) preferred.
• Solid written/verbal communication and organizational skills.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.

Nice-to-haves

• 3-5 years quality and/or complaint handling experience.
• Degree in science, nursing, or equivalent.

Benefits

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Work from home