Quality Assurance Specialist Quality Systems 3 OPENINGS

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Lets do this. Lets change the this vital role you will serve as a Quality Assurance Specialist responsible for specific systems within the QMS at ANC. This role provides an opportunity to collaborate with cross-functional stakeholders the Amgen global network and the site Quality Leadership Team ensuring the effective implementation maintenance and continual improvement of the QMS.

• Support and maintain Quality Systems including Deviations CAPA change control document control training risk management QA for QC audits and inspections.
• Track implementation progress monitor systems performance and report status in governance forums.
• Alert senior management of quality compliance and safety risks.
• Provide guidance and training to employees on quality processes procedures and compliance expectations.
• Support continuous improvement initiatives related to quality processes systems and compliance performance.
• Act as site SME for Quality Systems coordinate with global teams for alignment and best practices and ensure site effectiveness efficiency and compliance.
• Lead and/or participate in inspection readiness preparation and execution.
• Drive implementation of Quality Systems in compliance with Amgen Standards and Regulatory expectations.

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:

• High school diploma / GED and 10 years of Quality or Operations experience OR
• Associates degree and 8 years of Quality or Operations experience OR
• Bachelors degree and 4 years of Quality or Operations experience OR
• Masters degree and 2 years of Quality or Operations experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in a science field.
• Broad QA background supporting cross-functional quality operations.
• Experience facilitating quality governance meetings.
• Knowledge of risk management methodologies.
• Understanding of regulations standards and guidelines associated with Quality Management Systems.
• Strong organizational skills and demonstrated ability to drive projects to completion.
• Experience in monitoring performance and driving improvement.
• Demonstrated ability in problem solving.
• Capability to build strong and collaborative partnerships with stakeholders and partners and influence changes to ensure compliant efficient and effective operations.
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Experience participating in managing and/or responding to health authority inspections partner and corporate audits.
• Excellent written and verbal communication skills.

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship for this role is not guaranteed.

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.

Salary Range