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Quality Assurance Manager

1 month ago

Thousand Oaks, California, United States Amgen Full time
Transform the Lives of Patients with Amgen

At Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a member of our team, you'll play a critical role in helping us achieve this mission.

About the Role

We're seeking a highly skilled Quality Assurance Manager to join our Building 31 Plant QA team. As a key member of this team, you'll provide quality oversight for the GMP Receiving function, ensuring the review and release of incoming product and raw material shipments. Your expertise will be instrumental in maintaining the highest standards of quality and compliance.

Responsibilities
  • Lead and direct Incoming Quality Assurance staff, providing guidance and support to ensure their success.
  • Provide real-time QA oversight and support for GMP Receiving operations, collaborating with the warehouse supply chain team to resolve quality and compliance issues.
  • Ensure that changes impacting product quality are assessed according to procedures, and review and approve cGMP documents and records to ensure compliance.
  • Alert senior management to quality, compliance, supply, and safety risks, and support Quality during audits and inspections.
  • Maintain the safety of self and others, actively engaging with the Amgen EHSS safety program.
What We Offer

As a valued member of our team, you'll enjoy a comprehensive benefits package, including a Retirement and Savings Plan, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. You'll also have opportunities for career development, flexible work models, and a dynamic, collaborative culture.

Requirements
  • Doctorate degree or equivalent experience in a related field.
  • 3+ years of quality assurance experience, with a proven track record of leadership and management.
  • Excellent interpersonal and communication skills, with the ability to work in a team matrix environment.
  • Strong technical writing skills and experience creating deviation technical assessments.
Join Our Team

At Amgen, we're committed to fostering an inclusive environment where diverse, talented individuals can thrive. If you're passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.