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

Description

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

*Pay rate: $33-$35/hr. on W2.

*This is an Onsite role.

*Work

Schedule:
Wednesday - Saturday, 6AM - 4:30PM PST

*Job Summary: 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.

*Duties:

• 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

#IRI-LS


Job Type:
Contract


Pay:
$ $35.00 per hour


Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Ability to Relocate:

• Bothell, WA: Relocate before starting work (Required)

Work Location:
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