24 Aug
Specialist Quality Assurance
California,

Vacancy expired!

Top 3 Must Have Skill Sets:



Hard skills


  • Strong quality knowledge (4+ years of experience)

  • Strong knowledge of Quality systems and record ownership (4+ years experience)

  • Experience of LIMS




soft skill


  • Ability to prioritize, quickly shift priorities, and meet due dates as assigned




Day to Day Responsibilities:


  • Own quality records such as deviations, change records, and CAPAs

  • LIMS entries and approvals

  • Document processing including revisions and uploads to electronic system




Summary

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 own Change Control records internal to External Quality

  • Manage and drive Quality records to closure independently

  • Perform tactical batch disposition activities in support of lot release

  • Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)

  • Escalate risks or roadblocks to management

  • Drive timely decision making

  • Drive continuous improvements and Amgen 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)


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

Vacancy expired!


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