QC Specialist (Empower)

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.

QC Specialist

What you will do

Let’s do this! Let’s change the world!

In this vital role, you will be responsible for supporting the Chemistry as the Business Process owner (BPO) of Empower and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The QC Chemistry BPO will initially report directly to the Director of Quality Control.

This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Responsibilities

Under minimal supervision, the successful candidate will support the startup of the QC organization by:

• Leading the QC Chemistry activities including system qualification and validation of Empower 3 FR5 and other upgrades.

• Conduct training, troubleshooting, managing different aspects of Empower BPO role and attendance at meetings.

• Assisting with review of validation documents to support UPLC, HPLC equipment and CE computerized systems.

• Develop the Empower based method transfer plan.

• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.

• Assisting with procurement activities for consumables and critical reagents for lab start up.

• Own and manage Deviation, CAPA and Change Control records to support Quality Control.

• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vestal professional we seek is an effective leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality or Operations experience OR

• Associate’s degree and 8 years of Quality or Operations experience OR

• Bachelor’s degree and 4 years of Quality or Operations experience OR

• Master’s degree and 2 years of Quality or Operations experience OR

• Doctorate degree

Preferred Qualifications:

• Experience working in a GMP Quality Control Chemistry Laboratory.

• Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field.

• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.

• Experience with Chemistry Quality Control testing, including but not limited to: HPLC, UPLC, Concentration and USP-NF methods.

• Strong Leadership, Collaboration and Communication skills.

• Strong knowledge of laboratory techniques.

• Proficient in the use of Empower, method templates, and sample sets in Empower.

• Knowledge of related regulatory/industry considerations, compliance issues, templating and/or scientific discovery.

• Strong written and verbal communication skills including technical writing and presentation.

• Experience with equipment and method validation, verification, and transfer including the change control process.

• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect from 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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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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.