What are the responsibilities and job description for the QA Specialist position at Amgen?
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.
QA Specialist
What You Will Do
Let’s do this! Let’s change the world!
In this vital role the Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this vital role you will serve as Quality Assurance Specialist responsible for specific systems within the QMS at ANC. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site Quality Leadership Team to implement, maintain, and improve critical systems such as Quality Risk Management, Documentation Management, and Inspections.
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:
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:
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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
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.
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.
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.
QA Specialist
What You Will Do
Let’s do this! Let’s change the world!
In this vital role the Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this vital role you will serve as Quality Assurance Specialist responsible for specific systems within the QMS at ANC. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site Quality Leadership Team to implement, maintain, and improve critical systems such as Quality Risk Management, Documentation Management, and Inspections.
- Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
- Develop and/or own several Quality processes for the new Amgen facility such as Inspection Readiness, Document Management, and Quality Risk Management. Provides quality and compliance expertise & guidance; set up and maintain structural needs for these processes in line with Amgen requirements.
- Track implementation progress and monitor systems performance and report status in governance forums.
- Alert senior management of quality, compliance, and safety risks.
- Author/review/approve quality documents such as SOPs, risk assessments, and training materials.
- Support Lean Transformation and Operational Excellence initiatives.
- Serve as site SME for assigned Quality Systems, liaising with the global network for alignment and best-practice sharing and ensuring effectiveness, efficiency, and compliance at site.
- Lead and/or participate in inspection preparation and execution.
- Advise site on emerging trends and evolving expectations for assigned Quality Systems.
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 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
- Educational background in a science field
- Experience with Quality Management Systems, including Document Management, and Risk Management.
- 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, 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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
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.
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.
