QA Associate, Product Release | Costa Mesa, CA

Quality Assurance Associate, Product Release | Contract-to-Hire

Costa Mesa, CA (Orange County)

Pay rate: $25-$35/hr (DOE)

We're partnering with a life sciences organization in the Southern California region that operates within a highly regulated GMP manufacturing environment, supporting the development and production of complex biologics and/or sterile pharmaceutical products. They are known for strong quality standards, a collaborative technical culture, and a commitment to continuous improvement across manufacturing and QC operations.

Role Overview

The Quality Assurance Associate, Product Release supports GMP compliance across manufacturing operations by performing batch record review, documentation control, and quality release support activities. This role ensures all production and packaging activities meet internal procedures, regulatory expectations, and data integrity standards prior to product release. You'll work closely with Manufacturing, QA, and Documentation teams to support accurate, compliant, and inspection-ready batch records.

Key Responsibilities

• Perform QA review of manufacturing and packaging batch records for cGMP, GDP, and ALCOA++ compliance
• Review media fills, formulation, filling, and packaging documentation for completeness and accuracy
• Scan, verify, and manage manufacturing and QA batch documentation
• Assemble executed batch records and supporting documentation for archiving and submission
• Ensure accuracy and completeness across controlled documentation systems and databases
• Support logbook preparation and assignment across Manufacturing, QA, and Lab departments
• Maintain adherence to GMP documentation standards and data integrity principles

What We're Looking For

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field preferred (or AS with relevant experience)
• 2-4 years of experience in a GMP/pharmaceutical environment
• Experience in sterile, aseptic, or regulated manufacturing environments strongly preferred
• Strong understanding of GMP, GDP, and data integrity expectations (ALCOA++)
• Excellent attention to detail and documentation accuracy
• Strong organizational and communication skills

Please apply with an up-to-date copy of your resume to be considered.