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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Quality Assurance Specialist

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and impactful teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Amgen, one of the world’s leading biotechnology companies is investing $550 million to build a new multi-product drug substance bio-manufacturing facility in Holly Springs, North Carolina, a bio-manufacturing “hub” known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls “FleX Batch” manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen’s plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.

Let’s do this. Let’s change the world. The Quality Assurance Specialist is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start and will have a diverse scope during 2022-2024. In this role, you will provide quality oversight of the design, installation, commissioning & qualification and process qualification of facility and equipment. You will collaborate cross-functionally to ensure project timelines and turning points are met. The QA specialist will also support new employee orientation, administration of the learning management system, and implementation of the Amgen Quality Management System into the new facility. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance (e.g., deviation management, disposition, change control etc.). As the ANC Quality organization expands and the site is operational, the QA specialist role will then evolve and focus in on a specific area, such as quality systems, quality technical support, or oversight of operations.

Responsibilities:

• Perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
• Develop and lead new hire onboarding activities for ANC staff.
• Administration of the learning management system (LMS) for ANC site.
• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.
• Provide quality oversight for quality records including deviations/CAPA's, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate.
• Ensure that all activities & related documentation for facilities, equipment, materials and processes stay in sync with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods.
• Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Support continuous improvement initiatives.

Win

What we expect of you

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of Quality, Training and/or Manufacturing experience

Or

Bachelor’s degree and 5 years of Quality, Training and/or Manufacturing experience

Or

Associate degree and 10 years of Quality, Training and/or Manufacturing experience

High school diploma / GED and 12 years of Quality, Training and/or Manufacturing experience

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.

• Strong understanding of regulatory requirements and trends, and industry standards.
• Experience in either commissioning/qualification/validation or quality systems implementation and ownership.
• Ability to provide sound quality guidance and make data-driven, risk-based, decisions.
• Excellent written and verbal communication skills.
• Ability to work in a team matrix environment and build relationships with partners.
• Great attention to detail and high degree of accuracy in task execution and GMP documentation.
• Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.
• Demonstrated ability in problem solving and driving improvement.
• Strong leadership capabilities and experience applying GMP requirements in an operational setting
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

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