Quality Assurance Principal Specialist

Job overview

The Quality Assurance Principal Specialist role is onsite in Woodbury, NY, and may require up to 30% travel over the course of a year. Compensation is not specified. BioIVT provides research models and value-added services, including biospecimens, to support drug discovery and precision medicine research. The specialist provides senior independent oversight of the Quality Management System, ensuring quality systems, products, processes, and facilities meet applicable requirements. The role advances audit readiness, risk management, corrective actions, quality analytics, and continuous improvement across sites and functions.

What you'll do

• Lead assigned QMS processes and management reviews
• monitor quality metrics, audit results, CAPA effectiveness, and compliance trends
• interpret regulatory requirements
• oversee quality records and investigations
• support inspections and audits
• manage complaints, deviations, CAPA, and nonconforming materials
• lead root-cause investigations
• develop KPIs and reports
• oversee validation and product-release documentation
• conduct risk-based internal audits
• administer document control and eQMS processes
• train and mentor employees
• collaborate across laboratory, manufacturing, operations, and support functions.

What we're looking for

Skills & competencies

quality assurance principal specialist

quality management system

regulatory compliance

capa

audit readiness

quality analytics

bioivt

woodbury ny

travel up to 30%

gmp

glp

quality improvement

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, disability, life, hospital indemnity and accident insurance
• retirement plan with company match
• time-off policies
• company-sponsored events.

Why this role

The posting states travel may reach 30%. It seeks a bachelor’s degree in a scientific or related discipline and 7–10 years of progressive experience in quality, manufacturing, or operations in regulated industries; ASQ certifications are preferred. Benefits include medical, dental, vision, disability, life, hospital indemnity and accident insurance, retirement plan with company match, time off, and company-sponsored events.

About the employer

BioIVT is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.