GMP On-the-Floor QA Specialist – Cell Therapy

Cellipont Bioservices; Silver Spring (MD); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

401K match

Tuition Reimbursement

Flexible work schedules

Job summary

Cellipont Bioservices is seeking a Quality Assurance Specialist to provide real-time QA support for GMP manufacturing of cell therapies. The role includes on-the-floor monitoring, room release, and reviewing critical documentation to ensure compliance.

The candidate will perform audits, participate in root-cause analyses, and assist with lot disposition while maintaining and improving SOPs and QA systems. A Bachelor's degree and GMP experience are preferred.

Qualifications

• Bachelor's degree preferred with 2+ years of GMP industry experience.
• Knowledge of cell therapy manufacturing processes is a plus.
• Proven analytical and problem-solving abilities.
• Ability to learn new processes and work both in teams and independently.

Responsibilities

• Perform QA on-the-floor activities during manufacturing, including room release and in-process review.
• Audit manufacturing and support areas for adherence to procedures and quality standards.
• Review, disposition and documentation of batch records for accuracy and compliance.
• Act as first responder for quality issues and document investigations and corrective actions.
• Participate in root cause analysis using standard methodologies.
• Support lot disposition and evaluation of cell therapies.
• Write and revise GMP documentation and administer SOPs.
• Engage in site and corporate quality improvement initiatives.

Skills

Analytical skills

Troubleshooting

Decision making

Team collaboration

On-the-floor QA

Documentation review

Education

Bachelor's Degree

Tools

Microsoft Access

Excel

Job description

Cellipont Bioservices is seeking a Quality Assurance Specialist to provide real-time QA support for GMP manufacturing of cell therapies. The role includes on-the-floor monitoring, room release, and reviewing critical documentation to ensure compliance.

The candidate will perform audits, participate in root-cause analyses, and assist with lot disposition while maintaining and improving SOPs and QA systems. A Bachelor's degree and GMP experience are preferred.