Description

You will own quality assurance operations, including CAPA coordination, audit representation, and product compliance for distribution and manufacturing processes.

This role is on-site.

Responsibilities

• Manage the site CAPA program and shipment temperature monitoring validation.
• Act as the primary quality interface for FDA, supplier, and customer audits.
• Conduct investigations for product quality complaints, diversion, and distribution concerns.
• Execute QA holds in the warehouse management system and manage supplier audit data.
• Support new product introduction launches and master data management activities.

Required Skills

• Bachelor’s degree in a relevant technical field.
• 5+ years of experience in Quality Assurance, process support, engineering, or manufacturing.
• Deep knowledge of cGMP, cGDP, and distribution processes.
• Experience reviewing deviations and investigating compliance concerns.
• Ability to analyze complex technical data for product acceptance decisions.
• Proven track record serving as a quality representative during external audits.
• Strong problem-solving skills with experience resolving operational quality issues.

Key Skills

Education

Bachelor's degree