Quality Assurance Specialist, Batch Release

Pay Rate

$35/hour

Kelly® Science & Clinical is seeking a Quality Assurance Specialist, Batch Release for an 8-month contract position at a premier pharma company in Irvine, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

This client is a leading CDMO providing services for the entire drug product lifecycle. The Quality Assurance Specialist, Batch Release ensures adherence to cGMP regulations by reviewing records, releasing products, and conducting internal training while supporting investigations, audits, and continuous improvement of quality systems.

• Ensure compliance with cGMP regulations and internal standard operating procedures (SOP) across all activities.
• Review GMP records, including batch and laboratory documentation, and coordinate the release of components, raw materials, and finished products.
• Organize and manage internal training programs to keep personnel updated on GMP requirements and practices.
• Create, revise, and review SOPs, protocols, reports, and other GMP-related documentation.
• Participate in and review investigations of complaints, non-conformance, and deviation incidents.
• Support and coordinate stability studies for finished products.
• Assist with preparation and participation in internal, customer, and agency audits.
• Maintain quality systems, track and present quality metrics (KPIs), and collaborate on continuous improvement initiatives using electronic quality management systems.
• Other duties as assigned.

• Bachelor’s degree in Science or related field.
• 2+ years of experience in Quality Assurance in a GMP environment.
• Experience with 21 CFR 210/211 strongly preferred.