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Amgen QA Specialist in New Albany, Ohio


This role requires local presence at the New Albany facility near Columbus, Ohio.


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.

Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing high performing 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.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the facility will not only feature the best in-class assembly and packaging 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.


Reporting to the Senior Manager Quality, the QA specialist for the new Amgen Advanced Assembly and Final Product Operation facility will provide quality oversight support of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. QA specialist will also support 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.). Once the site is operation, the QA specialist will also provide quality oversight for manufacturing.

This role will require local presence at the New Albany facility near Columbus, Ohio.


What you will do

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for leading and directing cross functional staff as an informed Subject Matter Expert in the Quality deliverables under general supervision. A key aspect of this role is to utilize critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include validation documentation review & approval, SOP creation, review & approval, quality support in electronic batch record creation, quality approval of deviations & CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of records to completion.


  • Provides quality and compliance expertise & guidance and agrees on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment and information systems.

  • Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.

  • Provides quality oversight for quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate

  • Ensures that all activities & related documentation for facilities, equipment, materials and processes comply 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

  • Provides quality oversight for manufacturing and responsible for batch disposition.

  • Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

  • Support Lean Transformation and Operational Excellence initiatives


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:

  • Doctorate degree


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


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


  • Associate’s degree and 10 years of Quality and/or Manufacturing experience


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

Beyond that, additional preferred qualifications are:

  • Master's of Bachelor’s Degree in Science

  • Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry

  • Affinity with digital innovation, data sciences and Quality engineering

  • IS validation knowledge

  • Experience in review/approval validation documentation

  • 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, and identifying potential issues

  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

  • Experience working with dynamic cross-functional teams and proven abilities in decision making

  • Strong organizational skills, including ability to follow assignments through to completion

  • Strong leadership capabilities and proven experience applying GMP requirements in an operational setting

  • Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.


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.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.