On-the-Floor QA Associate, Biomanufacturing

Spherion Staffing, LLC; College Station (TX); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Job summary

Spherion Staffing, LLC is seeking a Quality Assurance Assistant to provide comprehensive quality oversight for cell and gene therapy manufacturing operations. You will review material-related cGMP documentation, support on-the-floor QA activities, and maintain controlled documents to ensure adherence to GMPs and regulatory standards.

The role interfaces with internal teams, suppliers, and clients to ensure materials and products meet quality specs prior to use or disposition.

Qualifications

• Bachelor's degree in a life science or related field or equivalent experience.
• 0–2 years of cGMP experience in Quality Assurance.
• Working knowledge of cGMP regulations (21 CFR 210/211, EU GMPs, ICH) and quality systems.

Responsibilities

• Acquire, review and evaluate material-related cGMP documentation (CoAs, specs, test results, BSE/TSE).
• Label, release, and track quarantined, released, and rejected materials to support operations.
• On-the-floor quality oversight across material receipt, warehousing, gowning qualification, and walkthroughs.
• Maintain GDP and perform on-floor record reviews for live operations.
• Manage document revisions and controlled documents per internal and regulatory standards.

Skills

Materials management exposure

Cleanroom gowning qualification

Audit readiness & records archiving

Education

Bachelor's degree in life sciences

Tools

MS Office

QMS

Job description

Spherion Staffing, LLC is seeking a Quality Assurance Assistant to provide comprehensive quality oversight for cell and gene therapy manufacturing operations. You will review material-related cGMP documentation, support on-the-floor QA activities, and maintain controlled documents to ensure adherence to GMPs and regulatory standards.

The role interfaces with internal teams, suppliers, and clients to ensure materials and products meet quality specs prior to use or disposition.