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Specialist Quality Complaints

Thousand Oaks, CA
Day to Day Responsibilities:    
  • Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
  • Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
  • Follow-up on corrective actions derived from investigations through completion.
  • Conducting and documenting the investigation.
  • May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
  • Other duties as assigned

Summary
  • BS in science, PM skills, Complaints experience within medical devices, detailed orientated.
  • Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
  • Accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution.

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

Authority
  • Owns complex quality record content
  • Determines situations which require escalation to management
  • Determines when a complaint dictates further investigation
  • Works under minimal direction
  • Proposes revisions to SOPs in area of responsibility

Basic Qualifications:
  • Doctorate degree OR
  • Master’s degree & 2 years of directly related experience OR
  • Bachelor’s degree & 4 years of directly related experience OR
  • Associate’s degree & 10 years of directly related experience OR
  • High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
  • 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
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • 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

"This posting is for Contingent Worker, not an FTE"
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