The Quality Assurance Specialist II provides comprehensive quality oversight for clinical and commercial cell and gene therapy manufacturing operations. This role integrates batch disposition, material management, QA floor support, and document control to ensure strict adherence to Good Manufacturing Practices (cGMP) and applicable regulatory standards. The position serves as a technical resource for continuous quality improvement, deviation/CAPA oversight, audit preparedness, and product release.
Responsibilities:
Batch Disposition & Review: Review executed batch records, environmental monitoring data, deviations, and change controls to facilitate timely product disposition and release. Material Management & Release: Review and approve cGMP documentation (e.g., Certificates of Analysis, material specifications, BSE/TSE statements) and manage the labeling and disposition of quarantined, released, and rejected materials. QA Floor Oversight: Provide real-time on-the-floor QA support during material receipt, warehouse handling, and manufacturing operations, ensuring adherence to Good Documentation Practices (GDP). Deviations & CAPA Management: Support investigation workflows, root cause analyses, and CAPA implementation as an owner or approver. Document Control & Compliance: Draft, revise, issue, and archive controlled standard operating procedures (SOPs) and quality records. Audit & Inspection Readiness: Maintain release tracking systems, trend quality metrics, identify compliance gaps, and ensure documentation is inspection-ready for regulatory and client audits.
Working hours: 8:00 AM - 5:00 PM
Skills:
Direct Quality Assurance experience within cell and gene therapy or advanced therapy medicinal products (ATMPs). Experience interfacing with external suppliers and contract clients regarding raw material specifications and release inquiries. Familiarity with internal audit execution, inspection readiness programs, and metrics tracking for process improvement. Experience supporting New Product Introductions (NPIs) in a regulated biomanufacturing facility.
Education:
Bachelors
Experience:
1-4 years
Qualifications:
Education: Bachelor???s degree in a life science or related field (or an equivalent combination of education and relevant industry experience). Experience: 2???3 years of cGMP experience in Quality Assurance, focusing on batch disposition, materials management, or QA floor support. Regulatory Knowledge: Solid understanding of cGMP regulations (21 CFR Parts 210/211, EU GMPs, ICH guidelines) and standard quality management systems. Technical Writing & Communication: Strong verbal and written communication skills, with experience drafting standard operating procedures and technical quality records. Cleanroom Compliance: Ability to achieve and maintain cleanroom gowning qualification. Software Proficiency: Familiarity with Microsoft Office Suite and electronic Quality Management Systems (eQMS). Physical Capability: Ability to lift up to 50 lbs and perform periodic bending, walking, and standing within office, warehouse, and cleanroom environments.
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
Batch Disposition & Review: Review executed batch records, environmental monitoring data, deviations, and change controls to facilitate timely product disposition and release. Material Management & Release: Review and approve cGMP documentation (e.g., Certificates of Analysis, material specifications, BSE/TSE statements) and manage the labeling and disposition of quarantined, released, and rejected materials. QA Floor Oversight: Provide real-time on-the-floor QA support during material receipt, warehouse handling, and manufacturing operations, ensuring adherence to Good Documentation Practices (GDP). Deviations & CAPA Management: Support investigation workflows, root cause analyses, and CAPA implementation as an owner or approver. Document Control & Compliance: Draft, revise, issue, and archive controlled standard operating procedures (SOPs) and quality records. Audit & Inspection Readiness: Maintain release tracking systems, trend quality metrics, identify compliance gaps, and ensure documentation is inspection-ready for regulatory and client audits.
experience 1-4 years
skills Direct Quality Assurance experience within cell and gene therapy or advanced therapy medicinal products (ATMPs). Experience interfacing with external suppliers and contract clients regarding raw material specifications and release inquiries. Familiarity with internal audit execution, inspection readiness programs, and metrics tracking for process improvement. Experience supporting New Product Introductions (NPIs) in a regulated biomanufacturing facility.
qualifications
Education: Bachelor???s degree in a life science or related field (or an equivalent combination of education and relevant industry experience). Experience: 2???3 years of cGMP experience in Quality Assurance, focusing on batch disposition, materials management, or QA floor support. Regulatory Knowledge: Solid understanding of cGMP regulations (21 CFR Parts 210/211, EU GMPs, ICH guidelines) and standard quality management systems. Technical Writing & Communication: Strong verbal and written communication skills, with experience drafting standard operating procedures and technical quality records. Cleanroom Compliance: Ability to achieve and maintain cleanroom gowning qualification. Software Proficiency: Familiarity with Microsoft Office Suite and electronic Quality Management Systems (eQMS). Physical Capability: Ability to lift up to 50 lbs and perform periodic bending, walking, and standing within office, warehouse, and cleanroom environments.
education Bachelors