Associate, Quality Compliance

Amgen; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to improving patients' lives through innovative solutions. As an Associate in Quality Compliance, you will play a vital role in ensuring high-quality execution of tasks and initiatives. This position offers the chance to work in a dynamic environment, where your contributions will directly impact the success of the Quality Risk Management team. With opportunities for personal and professional growth, you will thrive in a diverse and inclusive community that values your ideas and encourages you to take risks. Embrace the chance to make a difference with a leader in the biopharmaceutical industry.

Benefits

Healthcare benefits

Flexible work arrangements

Career development opportunities

Inclusive community

Comprehensive Total Rewards Plan

Qualifications

• Support Quality Risk Management team activities with GCP knowledge.
• Manage trackers and tools for quality compliance.

Responsibilities

• Coordinate project tasks ensuring delivery within scope and quality.
• Maintain quality risk management documentation and tools.

Skills

Good Clinical Practice

Project Management

Effective Communication

Critical Thinking

Data Management

Education

Bachelor's Degree in a relevant field

Tools

Quality Risk Management Tools

Job description

Career Category

Compliance

Job Description

Join our team at AMGEN Capability Center Portugal, ranked number 1 in Best Workplaces in Portugal (category 201-500 employees) by the Great Place to Work Institute. We have over 400 talented professionals from more than 38 nationalities, working across diverse areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs, and more. Located in Lisbon's city center, our office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. Our work at AMGEN truly matters in people's lives.

Associate Quality Compliance

LIVE

WHAT YOU WILL DO

Under general supervision, support the activities of the Quality Risk Management team. This role involves applying Good Clinical Practice knowledge and functional skills to ensure high-quality execution of tasks and initiatives. Responsibilities include managing trackers and tools, contributing to new process implementations, and providing proactive communication and updates to stakeholders.

Key Responsibilities:

• Coordinate project tasks ensuring delivery within scope, time, and quality standards.
• Maintain and update quality risk management tools and documentation.
• Support deviation, CAPA, and planned deviation management processes.
• Communicate status updates and escalate issues proactively.

WIN

WHAT WE EXPECT OF YOU

Key Capabilities:

• Understanding of SOP/Standards management and methods/technology used for knowledge management in R&D environment.
• Effective communication skills.
• Ability to develop innovative and creative solutions through interpretation and analysis.
• Deep disciplinary knowledge, leveraging business acumen and subject matter expertise.
• Employ project management techniques.
• Understanding of business priorities, strategy, and direction.
• Ability to integrate trends, data, and information into plans and recommendations.
• Act as a technical expert in GCP.
• Critical thinking skills.
• Ability to distinguish critical from non-critical issues.
• Strong attention to detail and proficiency in managing data and reports.

THRIVE - WHAT YOU CAN EXPECT OF US

• Opportunities to learn, develop, and advance within our global organization.
• A diverse, inclusive community where colleagues are empowered to share ideas, take risks, and act.
• Comprehensive Total Rewards Plan including healthcare, financial, and career benefits.
• Flexible work arrangements.

APPLY NOW

Objects in your future are closer than they appear. Join us.

CAREERS.AMGEN.COM

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer. We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. We provide reasonable accommodations for individuals with disabilities during the application and interview process. Please contact us to request an accommodation.