QA Specialist II (Continuous Improvement)

Location: Frederick, Maryland, United States; onsite Monday–Friday

Salary: $92,820–$120,120 per year, with potential eligibility for a discretionary annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

• Perform QA Operations activities to support GMP compliance, site quality standards, and regulatory requirements.
• Review manufacturing, laboratory, environmental monitoring, and quality-system documentation for accuracy and compliance.
• Support deviations, investigations, CAPAs, change controls, risk assessments, audits, inspection readiness, and effectiveness monitoring.
• Develop and maintain SOPs, work instructions, forms, training materials, quality records, dashboards, scorecards, and performance reports.
• Drive continuous improvement using Lean, Six Sigma, PDCA, A3, Value Stream Mapping, and root-cause analysis.
• Coordinate cross-functional improvement projects from planning and implementation through standardization and sustainment.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience; or an associate degree and at least 5 years; or a high school diploma/equivalent and at least 6 years.
• Experience supporting QA Operations or quality systems in a GMP-regulated environment.
• Experience with documentation control, compliance risk management, investigations, CAPAs, audits, or inspection readiness.
• Strong analytical, technical writing, presentation, and stakeholder-coordination skills.
• Ability to work onsite Monday–Friday in Frederick, Maryland.

Nice to have

• Experience in pharmaceutical, biotechnology, or cell-therapy operations.
• Lean, Six Sigma, project management, or related training or certification.
• Experience creating dashboards, metrics, visual-management systems, and project-tracking tools.

Culture & Benefits

• Work focused on developing cancer therapies and personalized cell therapies.
• Cross-functional collaboration with Quality Assurance, Quality Control, Manufacturing, MSAT, Engineering, Materials Management, Site Planning, and R&D.
• Benefits may include company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off and potential discretionary bonus and stock-based long-term incentives.