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

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. Hybrid option may be considered.

Live

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 apply problem solving skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include will provide Quality oversight of the development and implementation of the digital advancement opportunities for the new facility and will lead the development of the digital Quality strategy for the new facility and coordinate effective implementation of that strategy.

Responsibilities:

• Provides quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification of the digital manufacturing strategies for the new facility.

• Identify digital advancement opportunities for quality and lead their implementation into the new facility while ensuring Quality Processes are adhered to or adjusted as appropriate

• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure digital advancement is implemented in accordance with established procedures and applicable regulations. Partner with other facilities in the network to ensure implementation of standard processes, consistency, and continuous improvement.

• Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports.

• Ensures that all activities & related documentation for 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.

• Ensure relevant processes, equipment, system are validated and the validation is current.

• 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

Win

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

OR

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

Or

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

Or

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

Or

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

Preferred Qualifications:

• Master’s or Bachelor’s Degree in Science, Computer Science, Engineering

• Educated in a science, computer science, engineering 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 system experience with Automated Systems, Electronic Batch Record, Electronic Quality Management System, IIOT, Digital Control Tower, Advanced Analytics.etc.

• Proficiency with Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe

• Acrobat; database related platforms; knowledge of Trackwise, Vault Quality Docs, SAP, LIMS etc.

• Experience in review/approval validation documentation

• Skilled in technical writing and critical reasoning

• Excellent written and verbal communication skills, ability to work in a team matrix environment and establish relationships with partners

• Great attention to detail and high degree of accuracy in task fulfillment 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 demonstrate abilities in decision making

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

• 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

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.

The annual base salary range for this opportunity in the U.S. is $102,624 - $121,712.

In addition to the base salary, 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.

careers.amgen.com

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 cancers, 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.