Quality Assurance Associate

4 weeks ago

Bothell, United States SSi People Full time

Quality--QA Associate

This is an Onsite role

Work Schedule: Wednesday - Saturday, 6AM - 4:30PM EST


Job Description:

  • Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
  • Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
  • Inspects and releases intermediates or packaged drug product per specifications.
  • Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
  • Drafts and reviews specifications and SOPs.
  • Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
  • May provide guidance to less experienced staff.
  • Provides sitewide support during daily walkthroughs of GMP areas.


Requirements:

  • B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
  • 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
  • Knowledge of biotech product manufacturing.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus

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