Cell Therapy Quality Assurance & Systems Validation

Trillium Staffing; Boston (MA); On-site; USD 99,000 - 109,000; Full time

Job summary

Trillium Professional in Boston, MA is seeking a Quality Assurance Specialist with experience in cell therapy, quality systems validation and regulated environments. The role combines QA oversight, regulatory compliance and information-systems focus, with hands-on activities in cGMP/cGTP contexts.

Responsibilities include internal audits, CAPA, deviations, validation activities, and support for regulatory inspections, data integrity and database management.

Qualifications

• Experience in quality assurance, quality systems, compliance or validation within regulated labs or biotech.
• Understanding of cGMP/cGTP and regulatory requirements (FDA, FACT, CLIA, etc.).
• Experience with deviations, CAPA, RCA, FMEA and continuous improvement.

Responsibilities

• Support QA and continuous improvement in a regulated cell therapy and lab environment.
• Perform internal audits and assessments for regulatory compliance.
• Assist with regulatory inspections and sponsor audits.
• Lead quality processes including CAPA, RCA and deviation management.
• Validate new systems, instruments and methods; monitor data integrity.

Skills

Quality Assurance

Regulatory Compliance

cGMP/cGTP

Auditing

CAPA

Data Integrity

Validation

Quality Systems

Education

Bachelor's degree (life sciences)

Tools

LIS/LIMS

Job description

Trillium Professional in Boston, MA is seeking a Quality Assurance Specialist with experience in cell therapy, quality systems validation and regulated environments. The role combines QA oversight, regulatory compliance and information-systems focus, with hands-on activities in cGMP/cGTP contexts.

Responsibilities include internal audits, CAPA, deviations, validation activities, and support for regulatory inspections, data integrity and database management.