PHARMAFull-time
Specialist Quality Complaints
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)ONSITEPOSTED: 9/16/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Quality Specialist role responsible for end-to-end global product complaint processes, complaint investigations, record quality, procedural compliance and continuous improvement within Amgen's quality organization.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct medium-to-high complexity complaint investigations
- •Evaluate triaged product complaint records for procedural alignment
- •Own complaint records involving medium-to-high complexity investigations
- •Ensure accuracy and quality of complaint records
- •Complete assigned quality assessments according to procedures
- •Analyze complex situations using multiple information sources
- •Implement complaint processes in accordance with SOP requirements
- •Manage review and approval workflows for controlled documents in CDOCS
- •Support assigned projects through communication, status updates and tracker maintenance
- •Work shifts that may overlap with EU and US time zones when required
Reporting Hierarchy: Reports within Amgen's Quality organization; Works across site, functional and senior-management stakeholders in a matrixed environment; Exact reporting line and team size not specified
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree with 8-12 years of Quality experience OR Bachelor's degree with 10-13 years of Quality experience
- Bachelor's degree in a science field
- Ability to manage workload against timelines
- Familiarity with basic project management tools
- Ability to work in matrixed or team environments
- Understanding of quality systems and industry requirements
PREFERRED QUALIFICATIONS
- •Quality and/or manufacturing experience in biotechnology, medical device or pharmaceutical industry
- •Knowledge of QMS requirements
- •Understanding of API, drug substance, drug product, packaging or device manufacturing/testing processes
- •Experience leading functional teams
- •Experience using DAI principles for decision-making
- •Ability to negotiate positions using feedback from multiple stakeholders
REQUIRED VERIFIED SKILLS
Quality complaints
complaint investigation
quality management system
QMS
SOP compliance
quality assessments
product complaints
controlled documents
CDOCS
project management
manufacturing processes
quality standards
regulatory requirements
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive and comprehensive total rewards, local-standard benefits, professional development and wellbeing support
The posting states that Amgen provides competitive and comprehensive Total Rewards aligned with local industry standards but does not disclose specific salary or bonus/equity amounts.
ORGANIZATION CONTEXT & CULTURE
Amgen is a biotechnology company focused on researching, manufacturing and delivering innovative medicines across oncology, inflammation, general medicine and rare disease therapeutic areas.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Collaborative, innovative and science-based culture with emphasis on quality, inclusion, ethics, scientific advancement and serving patients.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Quality Specialist, Quality Manager and broader Quality Assurance, Quality Systems or Product Quality leadership roles, depending on experience and organizational opportunities.
APPLICATION ADVISORY
Emphasize 8-13+ years of relevant Quality experience according to degree pathway; highlight complaint investigation and QMS expertise; demonstrate pharmaceutical, biotech or medical-device quality experience; include examples of complex investigations, SOP compliance and controlled-document management; highlight cross-functional leadership and decision-making skills.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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