Quality Assurance Specialist IV (Cell Therapy)

Location: On-site in Pearland, Texas, United States. Schedule: 8:00 am–5:00 pm, Monday through Friday.

Company

hirify.global manufactures medicines and supports life-sciences customers through globally connected manufacturing sites.

What you will do

• Review and approve GMP documents, executed production records, deviations, investigations, CAPAs, change controls, and other quality records.
• Provide QA oversight for cell therapy manufacturing, including on-floor walkthroughs, aseptic processing, gowning, and cleanroom operations.
• Support deviation management, investigations, CAPA development, change control, material release, and lot disposition.
• Partner with Manufacturing, Quality Control, Quality Systems, Material Management, Facilities, and Engineering to resolve operational issues and improve compliance.
• Represent Quality Assurance in client meetings, audits, regulatory inspections, and inspection-readiness activities.
• Track quality-system records and support timely closure of compliance and continuous-improvement initiatives.

Requirements

• 5+ years of Quality Assurance experience in a GMP-regulated biopharmaceutical, cell therapy, or related manufacturing environment.
• Bachelor’s degree in Biology, Biotechnology, Life Sciences, Engineering, or a related scientific discipline.
• Experience supporting GMP manufacturing operations and reviewing and approving GMP documentation.
• Experience with deviations, investigations, CAPAs, and change controls.
• Knowledge of cGMP requirements, FDA regulations, quality systems, aseptic processing, cleanroom operations, and gowning requirements.
• Strong technical writing, root cause analysis, risk management, problem-solving, communication, and cross-functional collaboration skills.

Nice to have

• Cell therapy manufacturing experience.
• Experience with TrackWise and electronic quality management systems.
• Proficiency with Documentum, SAP, LIMS, and Microsoft Office applications.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance, short-term and long-term disability insurance, and employee assistance programs.
• Paid time off.