Job Description: Job Title: QA Associate
Location: Bothell, WA*100% onsite
Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PST*
Top Skills -

• Documentation Review experience
• Scientific Degree
• Experience working in a GMP environment

*Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.*
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
Additional Job RequirementsLab w/ blood & animal