QA Associate- Product Quality - Bothell, United States - Integrated Resources, Inc

Description

Job Description

Job DescriptionJob Title: QA Associate- Product Quality
Location: Bothell, WA
Duration: 12 months+

Pay Rate:$ 34.22/hr on w2.

This is an Onsite role.
Work Schedule: Wednesday - Saturday, 6AM - 4:30PM PST

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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