Quality Assurance Specialist III (GxP)

Location: On-site in Winston-Salem, North Carolina, USA

Salary: $91,500–$137,300 USD annually, plus discretionary bonus and benefits.

Company

hirify.global provides regulated laboratory services and kitting production support for life sciences customers.

What you will do

• Maintain GxP quality systems, including non-conformances, complaints, deviations, change management, CAPA, supplier quality, training, and document control.
• Schedule, perform, and report internal, supplier, and desk audits; serve as lead auditor and support regulatory, notified body, and customer audits.
• Analyze quality metrics, identify compliance risks, propose corrective solutions, and lead process mapping and continuous improvement initiatives.
• Review and approve validation protocols, reports, specifications, batch records, labels, certificates of analysis, and controlled quality documentation.
• Inspect and release raw materials, critical components, packaging, labeling, intermediate solutions, finished products, and services.
• Provide quality guidance, conduct site-wide training, support client-facing activities, and advise junior QA specialists.

Requirements

• Bachelor’s degree or equivalent combination of education and experience, plus at least four years of related experience in a life sciences or regulated environment.
• Experience independently conducting audits, performing technical and quality document reviews, batch release, and incoming inspection.
• Knowledge of root cause analysis, durable corrective and preventive actions, process improvement, and quality risk mitigation.
• Proficiency with Microsoft Word, Excel, and PowerPoint; strong organization, communication, writing, and prioritization skills.
• Ability to work independently with exceptional attention to detail in a minimally supervised environment.
• Fluent English reading, writing, speaking, and comprehension are required.

Nice to have

• Clinical quality experience.

Culture & Benefits

• Membership in the Society for Quality Assurance is required, with membership fees supported by the company.
• Health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid sick and vacation leave.
• Extended work hours may occasionally be necessary to meet business demands.