Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing 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.
Sr Specialist QA - Process Design and Performance
What you will do
Let’s do this. Let’s change the world. In this vital role you will develop new capabilities within Amgen North Carolina’s Quality systems and organization. This role will manage all Quality-related aspects of ANC facility design and capital projects, and lead all Quality procurement and budgeting activities. It will monitor quality-system performance and manage the site Quality team’s continuous improvement portfolio. The Senior Specialist will report directly to the Quality Site Head and will collaborate directly with cross-functional site leaders as well as OE and Quality counterparts across the Amgen network to enable excellence while ensuring the foundations of quality, compliance, and safety.
- Ensure Quality-team input into ongoing facility design discussion.
- Liaise directly with the capital project team on laboratory design updates.
- Lead equipment selection and procurement, including direct discussion with vendors.
- Track spend against budget and lead activities to support Financial processes.
- Track Quality’s Operational Readiness performance against plan and lead follow-up and escalation activities.
- Build and maintain Quality workforce models.
- Provide Quality input into Operations Network Risk Assessment process.
- Support the implementation of Quality Systems and processes, including forums such as Management Review, Work Center Team huddles, Investigation Advisory Board, and Change Review Board.
- Monitor performance of quality systems and business processes, and lead Management Review discussions.
- Lead identification of priority improvement opportunities, and manage CI portfolio.
- Lead Quality continuous improvement (CI) projects and Human and Organizational Performance (HOP) Learning Teams.
- Drive CI approach at ANC, using Operational Excellence (OE) and HOP methodologies and philosophies.
- Support site audits and inspections.
- Author and approve Quality documents, including SOPs, QRAs, protocols.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Quality, Operational Excellence, Engineering and/or Data/Information Systems experience
Or
Master’s degree and 4 years of Quality, Operational Excellence, Engineering and/or Data/Information Systems experience
Or
Bachelor’s degree and 6 years of Quality, Operational Excellence, Engineering and/or Data/Information Systems experience
Or
Associate’s degree and 10 years of Quality, Operational Excellence, Engineering and/or Data/Information Systems experience
Or
High school diploma / GED and 12 years of Quality, Operational Excellence, Engineering and/or Data/Information Systems experience
Preferred Qualifications:
- Operational Excellence Black Belt Certification
- Project Management experience
- Advanced skills in Smartsheet, Tableau, MES, and Microsoft tools
- Excellent written and oral communication skills, including demonstrated ability to successfully communicate to senior leaders
- Ability to translate strategy into concrete tactical objectives
- Proven ability to drive completion of strategic initiatives
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- A 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
- Flexible work models, including remote and hybrid 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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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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 to 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.