Cell & Gene Therapy QA Specialist II — Quality & Release

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

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.