Summary: Seeking a Supplier Quality Specialist with expertise in pharmaceutical manufacturing to ensure compliance and manage supplier quality assessments.

Job Requirements:

Bachelor of Science in Biology, Chemistry, or related field

3+ years relevant experience in a pharmaceutical manufacturing environment

Proficiency in Microsoft Office suite and data entry programs

Knowledge of cGMP guidelines

Preferred Skills:

Experience investigating exceptions and out of specifications

Root Cause Analysis expertise

Job Responsibilities:

Ensure site supplier assessments are current based on quality risk

Maintain operational compliance with US and international regulatory agencies (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP)

Serve as site auditor for suppliers and manage supplier schedule adherence

Author and manage supplier change control processes

Submit SCAR deviations to suppliers for defects found

Support FDA or other regulatory agencies during on-site audits

Act as site Quality SME on MSD