CareerPlan

CI Specialist 3

Durham, NC, usFull-time2026-11-03 → 2026-11-11

Core

Leads the implementation, maintenance, and continual improvement of the site Quality Management System (QMS) and drives high-impact projects to optimize cost, quality, and operational performance.

Role type

Senior IC Quality Management System (QMS) Lead

Builds

Site-wide QMS, EHS programs, and continuous improvement initiatives

Domain

Manufacturing / Quality Assurance / Operational Excellence

Required skills

QMS leadership, root cause analysis, corrective/preventive action planning, internal auditing, process improvement methodologies, EHS program development, change management, ISO standards compliance, cGMP knowledge, document control, risk management

Preferred skills

cGMP, SOC2+

Technologies

Microsoft Windows, MAC environments

Responsibilities

Provide leadership for QMS ensuring compliance with ISO and corporate standards; conduct root cause analysis and approve CAPAs for high-risk accounts; oversee internal audits and present QMS performance metrics to leadership; develop and deploy advanced process improvement methodologies; lead improvement projects including EHS and sustainability programs; monitor quality training requirements; ensure conformance with documentation and record retention standards; assist in developing proactive injury reduction programs; provide expertise in EHS initiatives including safety programs and change management.

Seniority

Senior, hands-on IC