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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Quality Assurance Specialist

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.

The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC). Because the function is engaged with sophisticated investigations and delivery of site strategic priorities, the role offers opportunity to engage broadly across the ARI site and within the network. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines. This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system.

• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
• Lead the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow Amgen’s processes and procedures.
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, efficiency verifications, standard operating procedures, batch records, and protocols.
• Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk Management
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential quality issues and ensure a state of inspection readiness
• Manage relationships within the Amgen network to help benchmark and share best practices.
• Drive continuous improvement initiatives at the site and network level to build value for the business.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The proactive professional we seek is a decisive candidate with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality Assurance experience OR
• Associate’s degree and 10 years of Quality Assurance experience OR
• Bachelor’s degree and 5 years of Quality Assurance experience OR
• Master’s degree and 3 years of Quality Assurance experience OR
• Doctorate degree

Preferred Qualifications:

• Demonstrated abilities in problem solving, and experience leading deviation/change control/ CAPA
• Excellent written and verbal communication skills with cross functional teams, network, and management.
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
• Experience with Regulatory inspections

Key Responsibilities include:

• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Develop and maintain a working understanding of applicable requirements and standard processes.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
• Lead the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow Amgen’s processes and procedures.
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, efficiency verifications, standard operating procedures, batch records, and protocols.
• Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk Management
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential quality issues and ensure a state of inspection readiness
• Maintain relationships within the Amgen network to help benchmark and share standard processes.
• Drive continuous improvement initiatives at the site and network level to build value for the business.

Thrive

What you can expect of us

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

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now for a career that defies imagination

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

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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