QA SPECIALIST II

Spherion Staffing, LLC; College Station (TX); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical

Prescription

Dental

Vision

AD&D

Life insurance

Short-term disability

401K plan

Job summary

Spherion Staffing, LLC is seeking a Quality Assurance Specialist II in Texas to oversee batch disposition, material management, and QA floor support in a cell and gene therapy setting. The role emphasizes deviation/CAPA oversight, document control, and audit readiness.

Qualifications include 1–4 years in QA within cGMP environments, a life science degree, and experience with eQMS and MS Office. This on-site position requires ability to lift up to 50 lbs and perform routine manufacturing tasks.

Qualifications

• Direct QA experience in cell and gene therapy or ATMPs.
• Experience interfacing with external suppliers regarding raw material specs and release inquiries.
• Familiarity with GDP and Good Documentation Practices (GDP).
• Experience supporting NPIs in regulated biomanufacturing environments.

Responsibilities

• Batch Disposition & Review: assess batch records, environmental data, deviations and change controls for timely disposition.
• Material Management & Release: review cGMP docs and manage labeling/disposition of materials.
• QA Floor Oversight: provide on-the-floor QA support during receipt, handling, and manufacturing.
• Deviations & CAPA Management: support investigations, root cause analyses, and CAPA implementation.
• Document Control & Compliance: draft/revise SOPs and quality records.
• Audit & Inspection Readiness: maintain release tracking, trends, and documentation for audits.

Skills

QA in ATMPs

Supplier QA liaison

GDP familiarity

NPI support

Education

Bachelor's degree in life science

Tools

eQMS

Microsoft Office

Job description

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.

Pay and Benefits

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.

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

Equal Opportunity Employer

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.