Senior Associate, Quality Complaints

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. 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.

Senior Associate Quality Complaints

What you will do

Let’s do this. Let’s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

• The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.
•  Evaluates and ensures triaged product complaint records align with applicable procedures
• Evaluates and owns complaint records with basic investigations
• Ensures quality of complaint records
• Completes assigned assessments per applicable procedures
• Applies analytical skills to evaluate sophisticated situations using multiple sources of information
• Implements the complaint process per SOP requirements
• Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
• Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance
• Due to the global nature of the role, must be willing to work in shift that overlaps with EU and US time zone, if required.
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Master’s degree and 4 to 7 years of Quality experience OR

Bachelor’s degree and 5 to 9 years of Quality experience OR

Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry

Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines Familiarity with basic project management tools
• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
• Experience in driving decision making by using the DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results
• Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format

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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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.

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