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. 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, 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.
Sr Associate Quality Assurance
Let’s do this. Let’s change the world. In this vital role you will be responsible to ensure that operations products are manufactured, tested, stored and distributed according to Good Manufacturing Practices (cGMP).
Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating completion of compliance and regulatory requests
Provides QA oversight for IQA and ensures area readiness as the IQA compliance representative. Support IQA quality events, change controls and risk assessments.
Supports ATO Management Review activities and metric control plan adherence
May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
Supports Continual Improvement initiatives, programs and projects
Alerts management of quality, compliance, supply and safety risks
Represents the Quality Assurance during audits and inspections
Completes required assigned training to permit execution of required tasks
Responsible for complying with Good Manufacturing Practices and Good Documentation Practices
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:
High school/GED + 4 years of Quality Assurance work experience
OR
Associate’s + 2 years of Quality Assurance work experience
OR
Bachelor’s + 6 months of Quality Assurance work experience
OR
Master's
Preferred Qualifications:
Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
Experience with Quality Management System (QMS) processes
Knowledge of quality metrics, Management Review processes, and continuous improvement methodologies.
Experience supporting regulatory inspections, partner audits, and internal quality audits.
Experience serving as a Quality Assurance representative within a manufacturing or quality organization.
Excellent written and verbal communication skills, including the ability to present information to leadership and regulatory inspectors.
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 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.
