Cell Therapy Manufacturing – Quality Assurance Specialist (IS/Quality Systems Validation)

Location: Boston, Massachusetts, United States; 100% onsite

Salary: $99,100–$105,800 per year

Company

hirify.global conducts cancer research and provides patient care in collaboration with Harvard Medical School-affiliated hospitals.

What you will do

• Monitor Cell Manipulation Core Facility quality systems and verify adherence to laboratory procedures.
• Perform, document, and report internal, external sponsor, regulatory, and accreditation audits.
• Maintain and improve quality programs for hematopoietic progenitor cells, therapeutic cells, and other cell-processing activities.
• Lead RCA, CAPA, Lean, and FMEA initiatives; track deviations, out-of-specification results, adverse events, and corrective actions.
• Review batch records, manufacturing records, quality-control records, clinical trial procedures, and product-release documentation.
• Support validation of instruments and methods, database and information-system monitoring, laboratory testing, and continuing education.

Requirements

• Knowledge of basic and complex principles of cell processing, laboratory quality systems, auditing, and compliance.
• Knowledge of FACT, FDA, JCAHO, AABB, CLIA, DOT, DPH, OSHA, cGMP, and cGTP requirements.
• Ability to use laboratory databases and spreadsheets to extract, analyze, and maintain data.
• Strong analytical reasoning, statistical analysis, problem-solving, communication, and documentation skills.
• Knowledge of aseptic technique, laboratory safety, infection control, equipment, and analytical instrumentation.
• Ability to work independently during off-shifts and accommodate schedule changes, weekend assignments, and a fast-paced laboratory environment.

Nice to have

• Experience operating and troubleshooting laboratory instruments and assay systems.
• Experience with a wide variety of analytical techniques and instrumentation.

Culture & Benefits

• Inclusive and equitable environment focused on cancer research, patient care, and public health.
• Opportunity to participate in professional meetings, publications, presentations, and institutional committees.
• Ongoing opportunities to upgrade professional and technical skills.
• Collaboration with staff, physicians, leadership, and Harvard Medical School-affiliated hospitals.