Cell Therapy GMP QA Specialist – On the Floor

Cellipont; Research Forest (TX); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

401K match

Tuition reimbursement

Employee referral bonuses

Flexible work schedules

Paid time off

Job summary

Cellipont Bioservices is seeking a Quality Assurance Specialist to monitor GMP manufacturing processes on the floor, ensuring compliance and real-time QA support for cell therapies.

The role includes reviewing documentation, auditing processes, and guiding GMP operations within a dynamic team. Strong analytical and problem-solving abilities are essential, with flexibility for overtime as needed.

Qualifications

• Bachelor's Degree preferred with 2+ years GMP experience.
• Knowledge of manufacturing processes related to cell therapy.
• Analytical, troubleshooting, and decision-making skills.
• Ability to quickly learn new manufacturing processes for clients.
• Ability to work in a team setting and independently.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and audits.
• Review batch records and supporting documentation for completeness and compliance.
• Lead root cause analysis using methods like fishbone, 5 whys, and comparative analysis.
• Write and revise GMP documentation; manage SOPs and related records.
• Participate in site and corporate quality and process improvement initiatives.
• Support evaluation and lot disposition of cell therapies.

Skills

Analytical skills

Troubleshooting

Decision making

Microsoft Access

Microsoft Excel

Microsoft Office

Database management

Record keeping

Education

Bachelor's degree in a related field

Tools

Electronic systems

Job description

Cellipont Bioservices is seeking a Quality Assurance Specialist to monitor GMP manufacturing processes on the floor, ensuring compliance and real-time QA support for cell therapies.

The role includes reviewing documentation, auditing processes, and guiding GMP operations within a dynamic team. Strong analytical and problem-solving abilities are essential, with flexibility for overtime as needed.