Amgen · 6 hours ago
Specialist Quality Complaints
Thousand Oaks, CA
Full-time
Hybrid
Entry, Mid Level
$109K/yr - $135K/yr
2+ years expAmgen is a biotechnology company focused on serving patients living with serious illnesses. In this role, you will ensure product complaint records are processed according to regulatory guidelines and provide guidance for complex complaint investigations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines
Evaluate subject matter expert assessments
Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution
Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information
Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process step metrics
Provide feedback and guidance to improve quality performance and prevent recurrence of issues
Develop solutions to technical problems of moderate complexity
Screen, evaluate, report and resolve record integrity issues
Raise potential Quality issues to Management and intensify issues that could impede the ability to close records according to action plans
Support department continuous improvement activities and projects in accordance with applicable regulations and business goals and objectives
Serve as a Subject Matter Expert for the team, responsible for reviewing device investigation reports and ensuring proper investigation
Support product hypercare by compiling and reviewing data
Representing the electromechanical team and working with the AI pilot project for the complaints process optimization
Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions, ensuring a thorough and strategic approach to issue resolution
Qualification
Required
Master's degree (or foreign equivalent) in Industrial Engineering or related field & 2 years of experience in the job offered or in an engineering-related occupation
2 years of experience in Manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes
2 years of Quality and manufacturing experience in biotech or pharmaceutical industry
2 years of experience with Quality Management Systems including Salesforce, Trackwise, or SAP
2 years of experience with Electronic Document Management Systems including Veeva Vault Quality, Box, and Share point
2 years of experience with Global regulations including FDA 21 CFR 820, International Organization for Standardization ISO 13485, FDA cGMP, and Device cGMP Regulations to align with regulatory guidelines during processing product complaints
2 years of experience operating project management tools including Microsoft Office, Smartsheet, or Miro
2 years of experience identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers
Benefits
Stock
Retirement
Medical
Life and disability insurance
Eligibility for an annual bonus or for sales roles, other incentive compensation
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, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
Morningstar.com
2026-02-04
2026-02-04
WSJ.com: US Business
2026-02-04
Company data provided by crunchbase