Complaints Investigator

Position Summary

The Complaints Investigator is responsible for conducting thorough, timely, and compliant investigations of product quality complaints. This role evaluates manufacturing, packaging, testing, and distribution data to determine root cause, identify trends, and ensure alignment with regulatory expectations and company quality standards. The investigator ensures documentation accuracy, data integrity, and effective communication with internal and external partners.

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Essential Job Responsibilities

Complaint Evaluation & Investigation

· Monitor complaints in-box.

· Initiates and completes investigations for all types of complaints.

· Requests retain testing in accordance with complaint(s), as applicable.

· Reviews and analyzes batch records, product release summaries, test data, variance investigations, and other relevant documents to determine relationship to the reported complaint.

· Differentiates between Product Quality Complaints, Adverse Events, and Product Inquiries and routes/escalates accordingly.

· Escalates complaints requiring priority handling or urgent investigation.

· Concisely summarizes investigation results and conclusions in written reports consistent with GMP and procedural requirements.

System Use & Documentation

· Performs all investigation-related data entry into the Customer Complaint Database (TrackWise).

· Generates reports from the TrackWise, evaluates output for accuracy, and ensures data integrity.

· Ensures all closed complaints are forwarded to appropriate clients/business partners.

· Revises SOPs and Work Instructions (WI) relevant to complaint handling, investigation, and documentation processes.

Metrics, Trends & Reporting

· Performs metrics for assigned product categories and evaluates complaint data for trends.

· Assists in routine monthly or periodic metrics reporting.

· Identifies potential issues or recurring trends requiring escalation or corrective action.

Cross-Functional & External Collaboration

· Works closely with contractors, clients, and business partners to maintain open communication and support investigation activities.

· Collaborates with cross-functional internal teams such as Manufacturing Sites, respective QA, QC, Regulatory Compliance, and Supply Chain.

· Serves as a contributing member of the team to achieve departmental and company outcomes.

Compliance & Ethical Conduct

· Ensures all investigation activities comply with cGMPs, FDA regulations, internal policies, and quality standards.

· Operates in accordance with the company’s Code of Conduct, Business Ethics, and all applicable regulatory, compliance, and safety requirements.

· Performs all work in support of the company’s Values.

· Performs special projects and other duties as assigned.