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

Description

Job Title: QA Associate- Product Quality

Location: Bothell, WA

Duration: 12 months+

This position is based onsite.

Work Schedule: Wednesday - Saturday, 6AM - 4:30PM EST

Responsibilities:

• Ensure shop floor quality presence and handle in-process materials and finished products.
• Investigate and resolve GDP errors.
• Perform batch record reviews.
• Ensure manufactured products meet regulatory standards.
• Assist in preparations for regulatory and customer audits.

Key Duties:

• Review and approve manufacturing formulation batch production records.
• Inspect and release intermediates or packaged products.
• Monitor processing stages for compliance.
• Draft and review specifications and SOPs.
• Track batch record errors and provide quality data to management.
• Provide guidance to junior staff members.
• Support daily walkthroughs of GMP areas across the site.

Requirements:

• B.S. in Biology, Chemistry, or related field preferred.
• 2+ years of experience in regulated environment, focusing on product quality.
• Understanding of biotech product manufacturing.
• Familiarity with US and EU cGMP regulations.
• Experience with Oracle, BMRAM, MES, Veeva Infinity is a bonus.