Quality Complaints Specialist

Amgen

Specialist Quality Complaints owner ensuring compliance and leading investigations in product complaints at Amgen. Facilitate cross-functional teams and drive continuous improvement for quality processes.

Posted 7/24/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $100,951 - $136,581 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in quality complaint management within the biotech or pharmaceutical industry, ensuring compliance with regulatory and SOP requirements while effectively leading cross-functional teams to resolve complex issues. Proficient in applying analytical skills and product knowledge to evaluate situations and implement corrective actions.

Highest-signal resume keywords

Quality Complaint ManagementRegulatory ComplianceCross-Functional Team LeadershipAnalytical SkillsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ExperienceManufacturing ProcessesCorrective ActionsComplaint InvestigationsData Analysis

Soft Skills

NegotiationWorkload ManagementProblem-Solving

Tools & Technologies

Project Management Tools

Industry Keywords

BiotechPharmaceuticalSOP RequirementsAPIDrug SubstanceDrug ProductPackagingDevice Manufacturing

About the role

Key responsibilities & impact

Amgen is seeking a Specialist Quality Complaints Standard/Advanced Complaint Owner and member of the Product Complaints and Surveillance team
The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations
Determines corrective actions with their effectiveness
Determines the steps necessary to ensure the proper level of control for product in distribution
Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records
Ensures quality of complaint records
Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
Completes prioritized work plans
Quickly advances issues that could impede the ability to close records according to action plans
Maintains compliance with local and global processes
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter specialist assessments
Raises potential Quality issues to Management

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of quality experience OR Bachelor’s degree and 4 years of quality experience OR Associate’s degree and 8 years of quality experience OR High school diploma / GED and 10 years of quality experience
4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to oversee multiple projects simultaneously
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to travel +/- 10% of time to domestic and international Amgen sites

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.