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.
Working hours: 8:00 AM - 5:00 PM
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).
Apply today!
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
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.
At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, 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).
key 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.
experience 0-1 years
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.
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).
education Bachelors