PHARMAFull-time
Associate- Quality Complaints
HYDERABAD (IN)ONSITEPOSTED: 9/23/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Manage assigned product complaint records and investigation activities within Amgen's global quality complaint process, ensuring procedural compliance, record quality, timely closure and continuous improvement.
ROLE DEFINITION & RESPONSIBILITIES
- •Evaluate and ensure triaged product complaint records remain aligned with applicable procedures
- •Manage customer feedback records through closure
- •Evaluate voided records and complete the required void process
- •Own and manage complaint records with limited information
- •Complete assigned assessments according to applicable procedures
- •Ensure the quality and completeness of complaint records
- •Drive complaint processes in accordance with SOP requirements
- •Review and approve controlled documents in CDOCS while following format, content, style, usability and quality requirements
- •Support assigned projects and tasks through timely delivery, communication, status updates and tracker maintenance
Reporting Hierarchy: Works within Amgen's Quality organization and collaborates with site, functional and senior-management stakeholders; specific reporting manager and team size are not stated in the posting.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree with 2-4 years of experience in Pharma, Life Sciences or Biotechnology
- OR Master's degree with 1-3 years of experience in Pharma, Life Sciences or Biotechnology
- Ability to manage workload within timelines
- Ability to work in a matrixed or team environment
- Understanding of quality requirements and QMS expectations
- Strong communication and writing skills
- Attention to detail
- Ability to understand and follow processes and instructions
PREFERRED QUALIFICATIONS
- •Quality or manufacturing experience in biotechnology, medical devices or pharmaceuticals
- •Understanding of API, Drug Substance, Drug Product, Packaging or Device manufacturing processes
- •Experience with Amgen CDOCS or comparable controlled-document systems
- •Experience with learning-management systems
- •MS Word and Excel proficiency
- •Status-report creation and distribution
- •Technical learning and process-improvement skills
REQUIRED VERIFIED SKILLS
Quality complaints
complaint investigation
quality management system
QMS
SOPs
product complaints
customer feedback
controlled documents
CDOCS
quality records
assessment
CAPA-related quality environment
MS Word
MS Excel
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive and comprehensive Total Rewards aligned with local industry standards; professional and personal growth support; collaborative and inclusive culture.
The posting states that Amgen provides a competitive base salary and comprehensive Total Rewards aligned with local industry standards, but no numeric salary range or bonus/equity amount is disclosed.
ORGANIZATION CONTEXT & CULTURE
Amgen is a biotechnology company focused on researching, manufacturing and delivering innovative medicines for serious diseases, with major therapeutic focus areas including Oncology, Inflammation, General Medicine and Rare Disease.
TEAM SIZE: Large global biotechnology organization; exact employee count not stated in the posting
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen describes its culture as collaborative, innovative, science-based, inclusive and patient-focused, with emphasis on ethical conduct, learning and professional growth.
EXPECTED CAREER ROADMAP
Potential progression may include Senior Quality Associate, Quality Systems, Quality Complaints or broader Quality Assurance roles, followed by specialist or management opportunities in pharmaceutical and biotechnology quality functions.
APPLICATION ADVISORY
Emphasize the required Pharma, Life Sciences or Biotechnology qualification and experience range; highlight complaint handling, quality systems or manufacturing experience; demonstrate SOP and QMS knowledge; mention experience managing records to closure and working within controlled processes; highlight MS Word and Excel skills; demonstrate attention to detail, documentation quality and timeline management; mention experience in matrixed environments and willingness to learn new systems.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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