QUALITY ASSURANCE ASSISTANT

Spherion; 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

The Quality Assurance Assistant provides comprehensive quality oversight for clinical and commercial cell and gene therapy manufacturing operations. This role integrates material management, floor QA support, and document control tasks to ensure strict adherence to Good Manufacturing Practices (GMPs) and applicable regulatory standards. Serving as a key interface among internal teams, suppliers, and clients, the position ensures that all materials and products meet established quality specifications prior to use or disposition.

Responsibilities

• Acquire, review, and evaluate material-related cGMP documentation, including Certificates of Analysis (CoAs), specifications, test results, and BSE/TSE statements. Label, release, and track the status of quarantined, released, and rejected materials to support continuous operations.
• Deliver on-the-floor quality oversight across material receipt, warehousing, gowning qualification, and manufacturing walkthroughs. Uphold Good Documentation Practices (GDP) and execute real-time record reviews on the floor.
• Assist with archiving completed documentation and managing controlled documents according to internal and regulatory standards. Support document revision workflows concerning disposition, materials, and manufacturing processes.
• Maintain audit readiness by ensuring records are properly organized, accurate, and readily retrievable for inspections.
• Maintain compliance with cGMP and ISO guidelines, promptly reporting process deviations, product defects, or regulatory findings. Follow site safety protocols across office, warehouse, and cleanroom environments.

Skills

• Direct exposure to materials management, raw material disposition, or floor QA support within a biomanufacturing or advanced therapeutics facility.
• Pre-existing cleanroom gowning qualification.
• Hands-on familiarity with inspection/audit readiness preparation and electronic document archiving systems.

Education

Bachelors

Experience

0-1 years

Qualifications

• Education: Bachelor???s degree in a life science or related discipline, or an equivalent combination of education and industry experience.
• Experience: 0???2 years of cGMP experience within a Quality Assurance setting.
• Regulatory & Industry Knowledge: Working understanding of cGMP regulations (21 CFR 210/211, EU GMPs, ICH guidelines), quality systems, and supply chain fundamentals.
• Technical & Software Tools: Proficiency in Microsoft Office applications and Quality Management Systems (QMS).

Working hours

8:00 AM - 5:00 PM

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Benefits

Spherion offers a comprehensive benefits package, including:

• medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).