Associate Quality Assurance (PQA)

• Provide oversight for Quality on-the-floor and operations support
• Support manufacturing operations and IPC testing through purposeful presence on the floor
• Support complex manufacturing investigations, change control, and unexpected result investigations
• Perform 12-hour shift (day/night)
• Support the maturation and continuous improvement of Amgen quality systems
• Participate in root cause investigations for non-conformances
• Review nonconformance investigations, change controls, and other quality records
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Support other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

• Bachelor’s Degree and 2 years of directly related experience
• Associate’s Degree and 4 years of directly related experience
• High School Diploma / GED and 6 years of directly related experience
• 1-3 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry
• Direct experience with bulk manufacturing of biopharmaceuticals preferred
• Demonstrated proficiency of written and verbal communication skills
• Ability and willingness to work any shift in support of operations that may include 24/7

Direct experience with bulk manufacturing of biopharmaceuticals

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
• Medical check expenses borne by the company