QA Specialist II

Responsibilities

• Perform activities to ensure compliance with regulatory requirements
• Develop Standard Operating Procedures (SOPs) to meet quality objectives
• Maintain routine programs to ensure compliance with GMP and GLP
• Review manufacturing, environmental monitoring, and quality control data
• Conduct inspections, statistical process control analyses, and audits
• Participate in writing annual product reviews and training programs
• Lead or coordinate investigations and CAPA recommendations
• Support Research and Development during new product start-ups

Requirements

• 4+ years of relevant experience in a GMP environment with a BS
• OR 2+ years of relevant experience in a GMP environment with a MS
• Working knowledge of GMP and/or GLP
• Knowledge of quality assurance systems, methods, and procedures
• Knowledge of FDA / EMEA standards and quality systems
• Basic knowledge of Six Sigma, LEAN, and root cause analysis tools
• Proficiency in Microsoft Office applications

Preferred Qualifications

• Prior experience in the pharmaceutical industry

About the Company

Gilead is a biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years, working to develop therapies that improve lives globally.