QA Complaint Associate

Job Title: QA Product Complaint Coordinator

Location: East Windsor, NJ

Type: Contract

Compensation: $25.00 - $35.00 per hour

Contractor Work Model: Onsite

Hours: 8:30am - 5:30pm



Responsibilities

• Handle product complaints, including initiating, receiving, processing, and closing complaints following SOPs.
• Prepare complaint samples for shipment to manufacturing for investigation.
• Interact with customers/reports daily to acquire necessary information for product complaint investigations.
• Review final investigations from manufacturing units for accuracy.
• Assist in the initial receipt and processing of adverse drug events (ADE) in line with SOPs.
• Support handling and processing of field alert reports to FDA when necessary.
• Analyze and summarize product complaint investigations independently, ensuring strict adherence to timelines.
• Contribute to various projects such as medical inquiry handling and adverse event intake.
• Maintain high standards of organization, communication, and documentation accuracy.
• Demonstrate strong customer service skills and high-performance work ethics.

Requirements

• Minimum of a Bachelor of Science degree or equivalent professional experience.
• At least one year of experience in Pharmacovigilance, Customer Service, or related Healthcare role.
• Proficiency in Excel and Word.
• Bilingual in Spanish preferred but not required.
• Ability to analyze and summarize investigations independently.
• Prior experience with SOPs and complaint handling is desirable.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.