Description

You will perform quality control sampling and inspection of incoming raw materials within a GMP environment. You own the sample lifecycle from receipt to release.

Responsibilities

• Execute QC sampling and inspection of incoming raw materials, ensuring strict adherence to documentation review protocols.
• Submit and coordinate sample shipments to internal and external contract testing labs, tracking the raw material QC sample lifecycle.
• Perform in-house testing using analytical and compendiated methods, including pH, Osmolality, Density, Conductivity, and visual inspection.
• Collaborate with Supply Chain, SQM, and QA to ensure timely raw material release and lot disposition.
• Support laboratory investigations, including OOS, deviations, and CAPAs, while maintaining laboratory cleanliness and managing material disposal.

Required Skills

• Bachelor's degree with 2+ years, or Associate degree with 4+ years, or High School degree with 5+ years of biotech/biopharmaceutical experience.
• Demonstrated experience working within a Good Manufacturing Practices (GMP) environment.
• Knowledge of GDP/GMP practices for documentation and packet review.
• Ability to follow analytical methods and compendial procedures accurately.
• Experience with data entry and compiling data for trending or investigations.
• Functional familiarity with Supply Chain, SQM, and QA workflows.

Preferred Skills

• Experience with quality systems and formal investigations.

Key Skills

Education

Master’s degree