Quality Lab Supervisor

Quality Lab Supervisor role at Thermo Fisher Scientific in Mebane, North Carolina overseeing laboratory quality assurance operations. Manages QC staff, batch record reviews, deviation management, and regulatory compliance while supporting cross-functional investigations and continuous improvement initiatives.

Responsibilities

• Supervise and manage QC laboratory staff including hiring, scheduling, performance evaluation, and professional development
• Oversee quality control processes, batch record reviews, and implementation of continuous improvement initiatives
• Evaluate QC findings and determine appropriate follow-up actions or corrective measures
• Participate in regulatory and customer inspections, serving as subject matter expert for investigations and nonconformances
• Lead root cause analysis and CAPA activities, providing recommendations for data review processes

Requirements

• Advanced degree plus 3 years quality assurance experience, or Bachelor's degree plus 5 years in pharmaceutical/biopharmaceutical quality
• Chemistry, Biology, Pharmacy, Engineering, or related scientific field preferred
• Comprehensive knowledge of cGMP, FDA regulations, ISO standards, and regulatory requirements
• Leadership experience supervising quality assurance teams
• Expertise in deviation management, CAPA, change control, batch record review, and root cause analysis
• Lead Auditor Certification from accredited agency preferred
• Proficiency with quality management systems and Microsoft Office applications