Senior Specialist Quality Control

Senior Specialist role managing laboratory equipment lifecycle, risk assessment, and operations at a pharmaceutical manufacturing facility. Responsible for equipment qualification, maintenance coordination, regulatory compliance, and cross-functional project leadership within assigned laboratory areas.

Responsibilities

• Serve as primary contact and coordinator for assigned laboratory IPT projects and areas
• Qualify, implement, manage, and decommission laboratory equipment with oversight of maintenance scheduling
• Lead corrective and preventative action initiatives; author deviation reports and SDLC documentation
• Facilitate cross-functional meetings and communicate project priorities, obstacles, and timelines to laboratory leadership
• Coach quality specialists and new personnel; support regulatory inspections and vendor contract negotiations

Requirements

• Bachelor's degree in life sciences, scientific discipline, engineering, or business
• Minimum 4 years GMP manufacturing or pharmaceutical quality/operations experience (2 years with Master's degree)
• Strong root cause analysis and quality decision-making capabilities
• Project management experience with cross-functional workstreams
• Proficiency in equipment lifecycle planning and regulatory management
• Excellent written and verbal communication skills
• Demonstrated analytical and critical thinking skills