QA Specialist II: On-The-Floor GMP & Compliance

Katalyst CRO; Oceanside (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Assurance Specialist II to provide hands-on support for production and quality operations in a biopharmaceutical setting. The role ensures product quality, regulatory compliance, and GMP adherence, supporting quality systems, inspections, audits, and continuous improvement initiatives.

The position emphasizes batch record review, deviation management, and on-the-floor QA oversight, with responsibilities spanning documentation, method transfers, CoA, and

Qualifications

• Relevant experience in quality assurance, quality control, or GMP manufacturing environments.
• Experience supporting deviation management, CAPA, and change control processes.
• Familiarity with batch record review, product release, and QA oversight activities.
• Experience working in regulated biopharmaceutical or life sciences environments.
• Background in analytical, virological, or microbiological Quality Control testing.

Responsibilities

• Provide hands-on support for production and quality operations, including batch record review and on-the-floor quality oversight.
• QA oversight and approval of Quality Control activities, including method transfers and CoA.
• Support and approve product shipments and packaging operations.
• Ensure timely review and closure of deviations, CAPAs, change controls, and investigations.
• Author and update SOPs, procedures, and forms.

Skills

Quality assurance

GMP compliance

Document control

Batch record review

On-the-floor QA

Education

Bachelor's degree with 2+ years

Master's degree

Associate degree with 4+ years

High school diploma with 5+ years

Tools

Veeva

Smartsheet

LIMS

Job description

Katalyst CRO is seeking a Quality Assurance Specialist II to provide hands-on support for production and quality operations in a biopharmaceutical setting. The role ensures product quality, regulatory compliance, and GMP adherence, supporting quality systems, inspections, audits, and continuous improvement initiatives.

The position emphasizes batch record review, deviation management, and on-the-floor QA oversight, with responsibilities spanning documentation, method transfers, CoA, and