Specialist Quality Assurance # JN -072021-67501

Thousand Oaks, California
Industry: QA Testers
Job Number: JN -072021-67501

 Description

  • Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

 

Key Responsibilities

  • Manage and own NC records for External Quality
  • Manage and own CAPA records for External Quality
  • Manage and drive Quality records to closure independently
  • Escalate risks or roadblocks to management
  • Drive continuous improvements and Client first mindset
  • Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)

 

Authority

  • Own Quality record content
  • Works under minimal direction
  • Identify opportunities and issues, then determine when escalation is necessary
  • Proposes revisions to SOPs in area of responsibility

 

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree & 4 years of directly related experience OR
  • Bachelor’s degree & 6 years of directly related experience

 

Preferred Qualifications:

  • 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • cGMP Experience
  • Ability to oversee multiple projects simultaneously
  • Able 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)


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