Job Details

Job Title: Quality Assurance Analyst II

3 Locations: Hybrid in any one

• Indianapolis IN USA 46268
• Deerfield, IL 60015
• Byhalia, MS 38611

Duration: 12 months

Rate Info: $50.00 - $61.00/hour

Supports onboarding and oversight of a 3PL partner to ensure compliance with GxP, FDA, and ISO standards for medical device and pharmaceutical distribution. Works with supply chain and operations teams to establish compliant processes, documentation, and quality systems. Involved in audits, vendor qualification, CAPAs, and performance monitoring.

Requirements:

Bachelor's degree + experience in regulated environments (pharma/medical devices), knowledge of GxP/FDA, and strong documentation and collaboration skills.

Key Skills

• GxP (GMP/GDP) and FDA regulations knowledge
• Quality Systems (SOPs, CAPA, deviations, change control)
• Vendor / 3PL management & audits
• Distribution & logistics compliance (including temperature-controlled products)
• Risk assessment and documentation skills
• Cross-functional collaboration (Supply Chain, Operations)
• Regulatory inspection support