29 JunTop 3 Must Have Skill Sets:
Quality Record Ownership
Supply Chain Management
Day to Day Responsibilities:
Open and Close Change Controls.
Manage teams and tasks to manage Change Controls.
Schedule and Lead teams to execute Change Control tasks.
Master’s degree and 4 years of Quality and/or Manufacturing experience
Bachelor’s degree and 6 years of Quality and/or Manufacturing experience
Associate’s degree and 8 years of Quality and/or Manufacturing experience
High school diploma / GED and 10 years Quality and/or Manufacturing experience
6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls
Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
Excellent interpersonal relationship skills.
Excellent oral and written communication skills.
Proficient with TrackWies; MSWord; MSExcel; MSPowerPoint
Ability to maintain remote working relationships with colleagues at other Amgen sites.
"This posting is for Contingent Worker, not an FTE"