Associate Quality Complaints

Amgen; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amgen is seeking an Associate to lead the end-to-end global complaint process, ensuring compliance with quality standards and procedures across markets.

You will evaluate records, drive investigations, and manage documentation in CDOCS and LMS, coordinating with cross-functional teams to close actions on time.

Qualifications

• Must have a degree with 3–4 years of pharma/biotech/engineering experience
• Engineering grads must have prior experience handling product quality complaints in pharma/medical devices
• Experience in quality systems and compliant document management is preferred

Responsibilities

• Owns end-to-end global complaint process and management system
• Ensures complaint processes remain fully compliant with quality standards
• Conducts complaint investigations with limited information and directs higher level investigations when needed
• Evaluates triaged product complaint records and ensures alignment with procedures
• Manages customer feedback records to closure
• Oversees review/approval flow in CDOCS of controlled documents
• Supports management of projects with timely status updates and documentation

Skills

Communication skills

Attention to detail

MS Office

Active listening

Education

Bachelor's degree in Pharma/Life Sciences/Biotechnology/Engineering

Master's degree in Pharma/Life Sciences/Biotechnology/Engineering

Tools

CDOCS

LMS

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. 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 from you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

• Bachelor's degree and 3 to 4 years of in Pharma/Life Sciences/Biotechnology/Engineering Experience
• OR
• Master's and 2-4 years of in Pharma/Life Sciences/Biotechnology/Engineering Experience
• Candidates with an Engineering qualification must possess prior experience handling product quality complaints in the pharma/medical devices industry

Preferred Qualifications

• Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
• Ability to successfully manage workload to timelines
• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
• 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)
• 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
• Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel)
• Verbal and written communication skills/writing skills
• Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies.
• Active listening skills
• Ability to understand and follow processes / process instructions
• Attention to detail

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, commi