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.*
Responsibilities
- Maintains shop floor quality presence; disposition in-process materials and finished products; 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 products 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.