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The candidate will be responsible for providing oversight for Quality on-the-floor and operations support, as well as supporting the manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (day/night).
Job Responsibility:
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
Requirements:
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
Nice to have:
Direct experience with bulk manufacturing of biopharmaceuticals
What we offer:
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