Specialist QA 1

Location: Holly Springs, North Carolina, United States

Salary: $104,287.35–$141,094.65 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide plant quality assurance oversight for bulk drug substance manufacturing and support real-time quality decisions.
• Ensure products, facilities, equipment, materials, processes, and records comply with cGMP, GDP, Good Documentation Practices, safety requirements, and applicable regulations.
• Review and approve batch production records, deviations, work orders, change controls, CAPAs, SOPs, validation documents, risk assessments, and training materials.
• Guide on-floor analytical testing and verify that production records and test results are complete and accurate.
• Support deviation investigations, change assessments, project implementation, and continuous improvement initiatives.
• Represent Plant Quality Assurance during audits and regulatory inspections, including interactions with health authorities.

Requirements

• High school diploma/GED with 10 years of relevant experience, or an associate degree with 8 years, bachelor’s degree with 4 years, master’s degree with 2 years, or a doctorate.
• Experience in quality, manufacturing, process development, or process engineering.
• Knowledge of cGMP biotech manufacturing in a multi-product environment, including cell banking, cell culture, and protein purification operations.
• Experience with quality management systems, exceptions, change control, risk management, disposition, root-cause analysis, and deviation investigations.
• Strong organizational, written, verbal communication, collaboration, and problem-solving skills.
• Familiarity with computer and automation systems such as MES, DeltaV, and PI data historian.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.