Work as Senior Associate Quality Complaints at Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Post : Sr Associate Quality Complaints

Job Description
• 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.

Candidate Profile
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

Additional Information
Experience : 4+ years
Qualification : Bachelor’s degree or Master’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-256197
End Date : 15th October 2026