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Quality Assurance Associate

3 months ago

Bothell, United States Aequor Full time

QA Associate - 58540-1

Location: Bothell, WA*100% onsite

Duration: 12 Months

Pay Rate: $35.71 per hour On W2


Work Schedule: Sunday-Wednesday, 9 PM - 7:30 AM 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 of 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.


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. Inspect and release intermediates or packaged drug products 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. Provide 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, and Veeva Infinity is a plus