Cell Therapy QA Specialist - Compliance & Audit Lead

Dana-Farber Cancer Institute; Boston (MA); Hybrid; USD 99,000 - 109,000; Full time

Job summary

Dana-Farber Cancer Institute in Boston, MA seeks a QA/QI Specialist for the Cell Manipulation Core Facility. You will supervise quality programs, conduct internal audits, and ensure adherence to regulatory standards across hematopoietic progenitor and therapeutic cell processing.

Responsibilities include maintaining documentation, training staff, and coordinating with industry and regulators to support IND submissions and FDA interactions.

Qualifications

• Be knowledgeable with regulatory and accreditation agencies to include: FACT, FDA, JCAHO, AABB, CLIA, DOT, DPH and OSHA.
• Perform and report on internal audits and assessments of laboratory processes to ensure compliance with JCAHO, AABB and FACT standards and FDA regulations and outside sponsor audits.
• Assist in leading the Quality Program for hematopoietic progenitor cells and other cell processing according to regulatory requirements.
• Lead quality processes (RCA, CAPA, Lean, FMEA) to improve department performance and report on lab outcomes.

Responsibilities

• Manage the laboratory Episode/Deviation Log and analyze deviations to identify trends and improvement opportunities.
• Review manufacturing and quality control records, document deviations, and initiate corrective actions.
• Develop and maintain policies, procedures, and training for CMCF personnel.
• Perform pre and post processing review of batch records for clinical trial compliance.
• Serve as an independent auditor/ verifier for assigned clinical trial procedures.

Skills

Regulatory compliance

Auditing

Quality systems

Statistical methods

Tools

Laboratory instrumentation

Data analysis software

Job description

Dana-Farber Cancer Institute in Boston, MA seeks a QA/QI Specialist for the Cell Manipulation Core Facility. You will supervise quality programs, conduct internal audits, and ensure adherence to regulatory standards across hematopoietic progenitor and therapeutic cell processing.

Responsibilities include maintaining documentation, training staff, and coordinating with industry and regulators to support IND submissions and FDA interactions.