Senior Associate Manufacturing – Manufacturing Investigations (Biotech)

Location: Holly Springs, North Carolina, United States

Salary: $86,048.05–$116,417.95 per year

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines to patients worldwide.

What you will do

• Manage deviation and environmental monitoring investigations within controlled environmental monitoring.
• Lead root cause analysis, CAPA development, and compliant documentation of investigation findings.
• Interpret environmental monitoring data, identify trends, and assess impacts on product quality and contamination control.
• Coordinate cross-functional investigations with manufacturing, process development, facilities and engineering, automation, EHS, and quality teams.
• Present investigation findings to regulatory inspectors, internal auditors, management, and other stakeholders.
• Develop tracking tools and improve investigation processes to support timely closure.

Requirements

• High school diploma/GED with 4 years of manufacturing or regulated-environment experience; or an associate degree with 2 years of experience; or a bachelor's degree with 6 months of experience; or a master's degree.
• Experience in manufacturing, microbiology, process development, or quality assurance, preferably in biotechnology or pharmaceuticals.
• Understanding of biologics drug substance manufacturing, environmental monitoring, and contamination control principles.
• Experience with root cause analysis, quality systems, compliance, and project management.
• Strong technical writing, verbal communication, interpersonal, and cross-functional collaboration skills.
• Experience leading investigations and using Veeva QMS for deviations and CAPAs is preferred.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus and stock-based long-term incentives.
• Paid time off and biannual company-wide shutdowns.
• Flexible work models, including remote arrangements where possible.
• Career development opportunities and a collaborative, cross-functional environment.