Specialist Quality Assurance #JN -042021-63113

Thousand Oaks, California
Industry: QA Testers
Job Number: JN -042021-63113

***Remote until Covid restrictions are lifted***

***Biotech/pharma preferred***

 

Description:

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

 Key Responsibilities:

  • Perform tactical batch disposition activities in support of lot release
  • Manage and own NC records for External Supply Quality
  • Manage and own CAPA records for External Supply Quality
  • Manage and own Change Control records internal to External Supply Quality
  • Manage and drive Quality records to closure independently
  • Provide tactical information to the networks (i.e., metrics to QMR, MR, data verification, trending, periodic monitoring, APR)
  • Escalate risks or roadblocks to management
  • Drive timely decision making using DAI principles
  • Drive continuous improvements and first mindset
  • Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, 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 & 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
  • 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)

 


Apply Online Apply Later