Senior Associate Quality Assurance

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Responsible for providing oversight for Quality on-the-floor and operations support, the Senior Associate Quality Assurance will support 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).

Main Responsibilities:

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  Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply

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  Independently complete routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports, deviation records and validation protocols etc.) and ensure key performance indicator met targeted metrics

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  Support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations

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  Act as Quality Assurance change control record assessor in change control activities and Quality Assurance contact for investigations.

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  Participate in regulatory inspections, and interact directly with regulatory inspectors

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  Coach site Quality Assurance professionals on resolution of routine operation issues

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  Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

• Masters Degree OR

• Bachelor’s Degree and 2 years of directly related experience OR

• Associate’s Degree and 4 years of directly related experience OR

• High School Diploma / GED and 6 years of directly related experience

• Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry

• Related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility

• Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production

• Good communication skills (technical writing and verbal communication/presentation) and the ability to collaborate with stakeholders

• Interacts effectively with variety of communication and working styles

• Experience with regulatory audits and inspections

• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

• Strong decision-making skills and ability to explain rationale to others

• Proactive in knowledge sharing with team members to help team enhance their skills 

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.