Senior Associate- Quality Assurance Validation (QAV)

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate- Quality Assurance Validation (QAV)

What you will do

Lets do this! Lets change the world!

The Quality Assurance Senior Associate is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start. The initial focus of the role will be to provide quality support of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. You will collaborate cross-functionally to ensure project timelines and milestones are met. Once the site is operational, this role will continue to provide validation support, as well as quality support for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.

• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site, as well as periodic reviews and other core day-to-day- tasks. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.

• Perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.

• Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.

• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, Forms, etc.

• Provide quality assistance on quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.

• Ensure 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.

• Support on-site audits and inspections.

• Support continuous improvement initiatives.

• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Quality and/or Operations experience OR

• Associates + 2 years Quality and/or Operations experience OR

• Bachelors + 6 months Quality and/or Operations experience OR

• Masters degree

Preferred Qualifications:

• Understanding of regulatory requirements, trends, and industry standards.

• Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.

• 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, identifying potential issues, and following assignments through to completion.

• Proven capability and experience applying GMP requirements in an operational and Quality Control setting.

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, well 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

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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.

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