Amgen Jobs – Specialist Quality Complaints

Website Amgen

Job Description:

The Specialist conducts complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution.

Job Responsibilities:

  • Anticipates and prevents potential issues with regulators
  • Escalates potential Quality issues to Management
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Provides guidance and technical advice
  • Evaluates subject matter expert assessments
  • Execution of regulatory and SOP requirements
  • Ensures quality of complaint records

Job Requirements:

  • Familiarity with basic project management tools
  • Ability to oversee multiple projects simultaneously
  • Associate’s degree and 10 years of Quality / Manufacturing experience
  • Ability to operate in a matrixed or team environment
  • Doctorate degree
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging,
  • Device manufacturing processes)
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to negotiate a position after taking feedback from multiple sources
  • Ability to successfully manage workload to timelines

Qualification & Experience:

  • High school diploma / GED and 12 years of Quality / Manufacturing experience
  • Master’s degree and 3 years of Quality / Manufacturing experience
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s degree and 5 years of Quality / Manufacturing experience
  • Bachelor’s Degree in a Science Field

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: General Business

Job Location: Cambridge, MA, US

Application Deadline: N/A

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