Sr Associate QA

Description

• Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply.
• Support routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics
• Support the maturation and continuous improvement of Amgen quality systems, including on-the-floor quality oversight, deviations, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
• Review and approve deviations, investigations, lab investigations, change controls, and other quality records (with focus on complex records). Participate in root cause investigations for deviations
• Support in regulatory inspections and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review

Qualifications

• Master’s degree OR
• Bachelor’s degree and 2 years of directly related experience OR
• Associate degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience.
• Preferred 3 to 5 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff