Description

Manage the sampling, inspection, and testing lifecycle of incoming raw materials within a GMP environment.

Responsibilities

• Perform QC sampling and inspection of incoming raw materials and associated documentation.
• Submit samples to internal and external labs and coordinate shipments to contract testing sites.
• Track the raw material QC sample lifecycle across all sites to ensure timely disposition.
• Review raw material packets using GDP/GMP practices and submit them to Quality Assurance for lot disposition.
• Support laboratory investigations, including OOS, deviations, and CAPAs related to sampling and testing.

Required Skills

• Bachelor's Degree with 2+ years of experience in a biotech/biopharmaceutical setting (or Associate Degree with 4+ years, or High School Degree with 5+ years).
• Experience operating within a cGMP environment.
• Knowledge of Supply Chain, SQM, and QA workflows.
• Proficiency in applying GDP/GMP practices to documentation review.
• Ability to perform analytical methods including pH, Osmolality, Density, and Conductivity testing.
• Experience with data entry and compiling data for trending or investigations.

Preferred Skills

• Experience with quality systems and formal investigations.

Key Skills

Education

Bachelor's degree