QA Specialist (Biotech)

Location: US - Ohio - New Albany

Salary: $104,287.35–$141,094.65 per year

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 quality oversight for daily manufacturing operations at the Final Drug Product plant.
• Review and approve SOPs, validation protocols and reports, electronic master batch records, and other controlled documents.
• Oversee deviations, CAPAs, technical change controls, work orders, production records, and test results.
• Lead deviation investigations, root cause analysis, resolution, and timely completion of quality records.
• Support batch disposition, audits, regulatory inspections, and interactions with regulatory agencies.
• Partner with Manufacturing, QC, Engineering, Supply Chain, and other functions on continuous improvement and operational excellence.

Requirements

• Doctorate degree; or a master’s degree with 2 years of Quality or Manufacturing experience; or a bachelor’s degree with 4 years; or an associate’s degree with 8 years; or a high school diploma/GED with 10 years.
• Experience in GMP/GCP operations or another regulated industry, preferably with a science degree.
• Experience reviewing and approving validation documentation and managing deviation investigations.
• Strong knowledge of GMP requirements, quality systems, documentation, problem solving, and root cause analysis.
• Ability to work independently, lead cross-functional activities, make decisions, and drive records and tasks to completion.

Nice to have

• Affinity with digital innovation, data sciences, and quality engineering.
• Experience supporting Lean Transformation and Operational Excellence initiatives.

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 and stock-based long-term incentives.
• Paid time off and career development opportunities.