Job Title: Complaint Investigator – Product Quality
Location: Princeton, New Jersey (Hybrid)
Job Summary: We are seeking a motivated professional to join our team supporting complaint investigation activities for product quality in the pharmaceutical and medical device sector. Our team values regulatory compliance, clear communication, and proactive problem solving to ensure product standards and customer safety are consistently upheld.
Responsibilities:
- Manage intake, triage, documentation, investigation, resolution, and closeout of product quality complaints while complying with industry regulatory requirements.
- Coordinate with cross-functional teams and shared service groups to support reconciliation processes and ensure timely completion meeting procedure requirements.
- Monitor complaint trends and manage critical complaints, notifications, and potential recall actions while summarizing complaint files for regulatory compliance.
- Generate, prepare, and present monthly and quarterly quality metrics and risk reports, including supporting quality management review meetings and projects.
Required:
- Bachelor’s degree plus a minimum of 2 years of quality assurance experience within the pharmaceutical and/or medical device industry.
- Strong knowledge of regulatory requirements, specifically 21 CFR Parts 210, 211, 820, related to complaint handling, investigations, and documentation.
- Proficiency in MS Office software and TrackWise, along with excellent analytical, writing, interpersonal, and communication skills.
- Ability to work effectively within a team environment and manage multiple tasks in a dynamic setting.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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