QA Specialist II - Raw Materials

PCI Pharma Services is seeking a QA Specialist II - Raw Materials to provide QA oversight to Materials Management and Quality Control, ensuring adherence to site SOPs and raw material specifications.

Requirements

• Bachelor’s Degree in a relevant scientific field
• Minimum 3 years’ experience in related GMP industry working in Quality Assurance, Quality Control, or groups which support receipt, inspection, or release of materials in a pharmaceutical or biotechnology facility
• Familiarity with USP and EP pharmacopoeias, and pharmaceutical raw material compendial testing
• Knowledge and ability to apply basic scientific principles to solve operational and quality tasks
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH