Specialist Quality Control Support - Change Control and Deviations

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.

Specialist Quality Control Support - Change Control and Deviations

What you will do

Let’s do this. Let’s change the world. In this vital role, you will lead a team responsible for QC Support. This group is responsible for Stability and Sample Management Teams. Responsibilities include the startup and validation of the laboratory electronic systems and equipment for the labs as well developing a complementary team of individuals. This role will support site start up and then transition to support of Amgen North Carolina commercial product release. The Specialist QC Support will report directly to the Director of Quality Control and as a member of this leadership team, you will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.

Change Control

• Develop and manage the change control process at ANC in line with FDA, EU GMP, and other regulations.
• Partner with system owners and cross-functional teams to assess impact and risk.
• Ensure documentation (justifications, impact assessments, validation needs, implementation plans) is accurate and complete.
• Present at Change Control Review Board (CRB) meetings and initiate changes in QMS (TrackWise or Veeva).
• Track and report change status to leadership, ensuring timely review and closure.
• Maintain strong communication with internal and external stakeholders.
• Apply strong project management, organization, and problem-solving skills.

Deviations

• Lead deviation investigations from initiation to closure in QMS (Veeva), meeting established timelines.
• Perform root cause analysis using industry tools (e.g., 5 Whys, 5M).
• Collaborate with QC teams (Chemistry, Bioassay, Microbiology, EM) to gather data and support investigations.
• Write clear, scientifically sound investigation reports with corrective actions.
• Assess product quality and patient safety impact.
• Develop, implement, and track CAPAs to prevent recurrence.
• Review historical deviations for trends and repeat events.
• Manage follow-ups, including effectiveness checks for CAPAs.
• Support audits and regulatory inspections by presenting investigation findings.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a dynamic team player with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Control experience OR
• Associate’s degree and 8 years of Quality Control experience OR
• Bachelor’s degree and 4 years of Quality Control experience OR
• Master’s degree and 2 years of Quality Control experience OR
• Doctorate degree

Preferred Qualifications:

• Degree in Pharmaceutical Sciences, Biotechnology, Chemistry, or Microbiology.
• Experience in Quality Control and Quality Assurance roles in pharmaceuticals or biopharma, with focus on deviations and change controls.
• Strong knowledge of cGMP regulations, quality systems, and regulatory compliance.
• Hands-on experience with change controls for equipment, computerized systems, or facility modifications.
• Skilled in technical writing, root cause analysis (e.g., 5 Whys, Fishbone), and investigation reporting.
• Familiarity with QMS software (TrackWise, Veeva).
• Excellent communication skills with cross-functional teams and regulatory authorities.
• Ability to manage multiple priorities independently in a fast-paced environment.

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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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.