Quality - QA Associate

Job Description: Job Title: QA Associate

Location: Bothell WA*100% onsite

Work Schedule: SundayWednesday 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 inprocess 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.

1. 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.

2. Inspects and releases intermediates or packaged drug product per specifications.

3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.

4. Drafts and reviews specifications and SOPs.

5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.

6. May provide guidance to less experienced staff.

7. 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 Sills: