Senior Specialist, Quality Assurance (Pharmaceutical Manufacturing)

Location: Blue Ash, Ohio, United States; onsite manufacturing role with a 12-hour 2/2/3 schedule. Day shift: 6:00 a.m.–6:30 p.m. or night shift: 6:00 p.m.–6:30 a.m. Travel of approximately 5–10% may be required.

Salary: $70,000–$115,000 base pay per year, depending on location, experience, qualifications, skills, and knowledge.

Company

hirify.global is a technology-focused biomanufacturing company building end-to-end manufacturing solutions for pharmaceutical and combination products.

What you will do

• Provide quality oversight and approval for manufacturing, laboratory, and quality system activities, including batch disposition, investigations, deviations, CAPAs, change controls, risk assessments, and validation.
• Review documentation and monitor quality systems supporting inspection, assembly, packaging, testing, incoming materials, and product release.
• Lead or support root cause analyses, technical troubleshooting, product quality investigations, and continuous improvement initiatives.
• Represent Quality in cross-functional projects, technology transfers, process improvements, audits, inspections, regulatory interactions, and new product introductions.
• Review and maintain quality records, procedures, specifications, validation documents, and quality metrics.
• Provide technical guidance and training to technicians and partner with Manufacturing, Technical Operations, Supply Chain, MSAT, Engineering, and Project Management.

Requirements

• Strong experience with equipment, utilities, facilities, technology transfer, statistical analysis, investigations, risk management, process validation, and/or Quality oversight.
• Experience in a regulated pharmaceutical, biotechnology, or medical-device environment with cGMP, 21 CFR, ISO 13485, ISO 14971, EMA, PDA, or ICH requirements.
• Knowledge of Design Controls, change management, quality management systems, and regulatory guidance for technology transfer and validation.
• Experience supporting audits and regulatory inspections, using risk assessment tools such as FMEA, HACCP, LOPA, or PHA.
• Strong leadership, communication, technical writing, problem-solving, organization, and cross-functional collaboration skills.
• Work authorization sponsorship or visa support is not available for this position. Proficient computer skills and experience with Microsoft Office are required.

Nice to have

• Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or a related field.
• At least 5 years of combined quality assurance and/or validation experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Experience with cGMP inspection, medical-device assembly, packaging, sterile manufacturing, multi-product facilities, and cGXP requirements.

Culture & Benefits

• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, vision, life, and disability insurance.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Family-building benefits, tuition reimbursement, and caregiving support.
• Work includes sitting, standing, walking, bending, repetitive motion, chemical usage, and required personal protective equipment.