Senior Product Quality Surveillance - Commercial Complaints

Integrated Resources Inc.; Exton (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company, Integrated Resources Inc., seeks a Senior Specialist in Product Quality Surveillance focused on commercial complaints. The role involves ensuring product quality across multiple functions, leading complaint investigations, and maintaining compliance with regulatory standards. Ideal candidates will have a strong scientific background, extensive quality assurance experience, and familiarity with both device and drug oversight.

Qualifications

• 5+ years of experience in a GMP environment, with a focus on QA and regulatory compliance.
• Strong scientific background for product data analysis and risk assessment.
• Working knowledge of both US and EU regulations including cGMPs.

Responsibilities

• Manage product quality complaints and conduct trend analysis.
• Support onboarding of new products into quality systems.
• Ensure compliance with regulatory standards and assist in inspections.

Skills

cGMP Knowledge

Regulatory Compliance

Data Analysis

Complaint Management

Quality Risk Assessment

Education

Bachelor’s degree in a relevant field

Master’s degree (optional)

Tools

TrackWise

Master Control

Microsoft Office

Job description

A leading company, Integrated Resources Inc., seeks a Senior Specialist in Product Quality Surveillance focused on commercial complaints. The role involves ensuring product quality across multiple functions, leading complaint investigations, and maintaining compliance with regulatory standards. Ideal candidates will have a strong scientific background, extensive quality assurance experience, and familiarity with both device and drug oversight.