Associate Quality Compliance

Amgen; United States; Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Retirement plan

Group medical, dental & vision

Life & disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is seeking an Associate Quality Compliance professional to support the R&D Quality Management System. You will manage controlled documents like SOPs and work instructions, ensuring development, maintenance, and retirement align with global standards and GCP regulations.

You will collaborate across functions to drive approvals, perform quality checks, and help maintain inspection readiness. A strong emphasis on detail, communication, and workflow management is required.

Qualifications

• Basic qualifications include a high school diploma or GED with related experience, an Associate’s or Bachelor’s degree with experience.
• Preferred qualifications emphasize attention to detail, strong writing and communication, and ability to manage document workflows.

Responsibilities

• Execute and track document workflows in the controlled document management system (CDOCS).
• Perform impact analysis for controlled documents to support business requests.
• Maintain document metadata and ensure accuracy during edits and reviews.
• Conduct quality checks for consistency and regulatory compliance.
• Support inspections and audits by providing requested documents.

Skills

Attention to detail

Document control

Verbal & written communication

Workflow management

Education

High school/GED + 2 years related experience

Associate’s + 6 months related experience

Bachelor’s degree

Tools

CDOCS

Job description

Career Category

Quality

Job Description

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

Associate Quality Compliance

What you will do

Let’s do this. Let’s change the world. The Controlled Documentation Associate plays a critical role in supporting Amgen’s R&D Quality Management System through the execution and maintenance of controlled document workflows. This role ensures that R&D controlled documents, such as SOPs and work instructions, are developed, maintained, and retired in compliance with global standards and GCP regulations. The associate will collaborate across functions to facilitate document approval processes, conduct quality checks, and support inspection readiness activities.

Roles & Responsibilities:

• Execute and track workflows for creation, revision, and obsoletion of documents with the controlled document management system (CDOCS).
• Perform controlled document impact analysis in support of business requests and initiatives.
• Maintain document metadata in CDOCS.
• Conduct quality checks, editing, and proofreading of documents for consistency and compliance.
• Monitor document workflows, notify stakeholders of pending tasks, and follow up to ensure timely completion.
• Support inspections and audits by retrieving and compiling requested documents.

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 go getter with these qualifications

Basic Qualifications:

• High school/GED + 2 years of directly related experience OR
• Associate’s + 6 months directly related experience OR
• Bachelor’s

Preferred Qualifications:

• Strong attention to detail with proven ability to perform quality control reviews.
• Working knowledge of document control tools and best practices.
• Excellent verbal and written communication skills.
• Ability to manage document workflows and prioritize tasks.

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, 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.

Application deadline

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

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

USD -USD