Job Information
Amgen Associate Quality Complaints in Hyderabad, India
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.
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 Associate conducts complaint investigation tasks related to customer feedback records and records with limited information available, as well as records that might not require any investigation. The Associate also determines if complaint investigations require critical issue for further higher level investigation.
Evaluates and ensures triaged product complaint records stay in sync with applicable procedures
Evaluates and manages customer feedback records to closure
Evaluates records that have been determined to be voided and completes the void process
Owns records with limited information
Completes assigned assessments per applicable procedures
Ensures quality of complaint records
Drives the complaint process per SOP requirements
Owns or handles 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Bachelor’s degree and 0 to 3 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences' experience OR
Diploma and 4 to 7 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences' experience
Preferred Qualifications:
Basic to Intermediate understanding of other tools (e.g. Smartsheet, Veeva) to support the development and management of documents, business/system processes and related data.
Knowledge of Microsoft copilot, open AI Chat GPT, and other AI/Large Language Model (LLM) tools.
Understanding of key regulations (e.g. EMA, FDA) and ethical guidelines (GxP) governing the Pharmaceutical industry
Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reports
Experience in at least one of the following areas: Quality Management, Document Management, Quality Assurance, Learning Management / Learning Management Systems (LMS)
Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel, Visio)
Practical experience with handling projects / multiple projects at the same time
Verbal and written communication skills/writing skills
Process/business writing skills
Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies.
Active listening skills
Critical/problem-solving/logical thinking skills and process oriented
Ability to understand and follow processes / process instructions
Attention to detail
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.
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.