Sr. Associate QA

1 month ago


Dublin, Dublin City, Ireland Amgen Full time

Description

Provide tactical support activities to Site Leads across multiple Quality Systems and Processes through the Regional Work Cell Team.

Key Responsibilities

  • Batch record archival
  • Log LIMS batches
  • LIMS sample plan creation/update
  • Enter LIMS data
  • Certificate of Analysis creation, as necessary
  • Enter SAP master data
  • Train on required Quality Systems to perform required tasks
  • Escalate risks or roadblocks to managementBatch disposition activities

Authority

  • Own basic quality record and document content
  • Determines situations which require escalation to management
  • Works under general direction

Basic Qualifications :

  • Master's degree OR
  • Bachelor's degree & 2 years of directly related experience OR
  • Associate's degree & 6 years of directly related experience OR
  • High school diploma / GED & 8 years of directly related experience

Preferred Qualifications :

  • 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • cGMP Experience
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • 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)


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