Senior Specialist II, Quality Assurance

Location: Blue Ash, Ohio, United States; onsite

Salary: $90,000–$123,750 per year

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for pharmaceutical products.

What you will do

• Provide quality oversight for manufacturing, laboratory, inspection, assembly, packaging, testing, and product release activities.
• Review and approve investigations, deviations, CAPAs, change controls, validation documents, risk assessments, and technology transfer materials.
• Serve as a quality subject matter expert during internal, customer, and regulatory audits and inspections.
• Support incoming material and component sampling, testing, disposition, and quality decision-making.
• Partner with Manufacturing, Technical Operations, Supply Chain, MSAT, Engineering, and Project Management on product introductions and process improvements.
• Lead risk assessments, troubleshoot quality issues, drive corrective actions, and mentor QA staff and non-QA partners.

Requirements

• Advanced expertise in equipment, utilities, facilities, technology transfer, statistical analysis, investigations, risk management, process validation, and quality oversight.
• In-depth knowledge of GMP validation and technology transfer guidance, including 21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, and ICH requirements.
• Experience with design controls, cross-functional change management, quality management systems, and complex compliance decisions.
• Experience leading risk assessments using methods such as FMEA, HACCP, LOPA, PHA, and Lean tools.
• Experience serving as a subject matter expert during customer audits and regulatory inspections.
• Ability to travel approximately 5–10% and proficiency with Microsoft Office applications.

Nice to have

• Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or a related field.
• At least 7 years of combined quality assurance and/or validation experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Experience with cGMP inspections, medical device assembly, packaging, sterile manufacturing, or multi-product facilities.
• Experience with regulatory inspections, technical troubleshooting, and root cause analysis.

Culture & Benefits

• Monday–Friday schedule with 8-hour workdays.
• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
• Paid vacation, paid holidays, other paid leave, tuition reimbursement, and caregiving support.
• Visa and work authorization sponsorship or support is not available.