Quality Assurance Specialist - Quality Systems

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Quality Assurance Specialist- Quality Systems

What you will do

Lets do this. Lets change the world. The Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this vital role you will serve as Quality Assurance Specialist responsible for specific systems within the QMS at ANC. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site Quality Leadership Team to implement, maintain, and improve critical systems such as Quality Risk Management, Documentation Management, Deviations/CAPAs, Change Controls, Site Management Review, and Inspections.

• Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
• Develop and own several Quality processes for the new Amgen facility, e.g. Management Review, Internal Audits, Document Management, Deviations and Change Control. Provides quality and compliance expertise & guidance; set up and maintain structural needs for these processes in line with Amgen requirements.
• Track implementation progress and monitor systems performance and report status in governance forums.
• Alert senior management of quality, compliance, and safety risks.
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, and training materials.
• Support Lean Transformation and Operational Excellence initiatives
• Serve as site SME for assigned Quality Systems, liaising with the global network for alignment and best-practice sharing and ensuring effectiveness, efficiency, and compliance at site.
• Lead and/or participate in inspection preparation and execution.
• Advise site on emerging trends and evolving expectations for assigned Quality Systems.
• Provides quality oversight for quality records including deviations/CAPAs, change controls assuring adherence to procedural requirements and confirming assessments and evaluations of stakeholders are complete and accurate.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality or Operations experience OR
• Associates degree and 8 years of Quality or Operations experience OR
• Bachelors degree and 4 years of Quality or Operations experience OR
• Masters degree and 2 years of Quality or Operations experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in a science field
• Experience with Quality Management Systems, including Deviations, Change Control, Document Management, and Risk Management
• Understanding of regulations, standards and guidelines associated with Quality Management Systems.
• Strong organizational skills and ability to drive projects to completion.
• Experience in monitoring performance and driving improvement.
• Ability in problem solving.
• Capability to build strong and collaborative partnerships with collaborators and partners and influence changes to ensure compliant, efficient, and effective operations.
• Experience working with dynamic cross-functional teams and abilities in decision making
• Experience participating in, managing, and/or responding to health authority inspections, partner and corporate audits.
• Excellent written and verbal communication skills.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.