Amgen-posted 7 months ago
Full-time • Entry Level
Hybrid • New Albany, OH
Chemical Manufacturing

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

  • Provide QA guidance and support to AOH warehouse Operation.
  • Perform Quality Review of all inbound and outbound related documentation at AOH.
  • Support different QA related projects/systems.
  • Establish effective working relationships with warehouse supervisors and staff, Incoming QA and production leads, production and facilities and engineering.
  • Provide QA oversight to the warehouse operations.
  • Support multiple warehouse functions from receiving materials to shipping finished goods.
  • Ensure compliance and support resolution of potential nonconformance events.
  • Advise staff on proper documentation as needed.
  • Lead, mentor, and coach personnel on quality matters.
  • Review and approve inbound and outbound processes and other GMP documentation.
  • Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
  • Review and approve Deviation, CAPA, and Change Control records.
  • Participate in self-led inspections and provide support during internal/external regulatory inspections.
  • Support Lean Transformation and Operational Excellence initiatives.
  • Adhere to safety rules and maintain a safe work environment.
  • High school/GED + 4 years quality assurance work experience.
  • Associate's + 2 years quality assurance work experience.
  • Bachelor's + 6 months quality assurance work experience.
  • Comprehensive employee benefits package.
  • Retirement and Savings Plan with generous company contributions.
  • Group medical, dental and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
  • Discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off plans.
  • Flexible work models, including remote and hybrid work arrangements.
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