Quality Specialist II - Complaints

Quality Specialist II at Thermo Fisher Scientific ensures compliance with GMP and FDA regulations in pharmaceutical and biotech manufacturing. The role involves managing quality systems, conducting investigations, and supporting continuous improvement across multiple product lines in Greenville, North Carolina.

Responsibilities

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements
• Conduct deviation investigations, CAPA processes, and root cause analysis activities
• Implement and support continuous improvement initiatives across manufacturing operations
• Maintain quality management systems documentation and lead internal audits
• Collaborate with cross-functional teams to manage quality across multiple product lines

Requirements

• Advanced degree with no experience, or Bachelor's degree with 2+ years in pharma/biotech manufacturing or quality assurance
• Knowledge of cGMP regulations, ISO 9001/13485 standards, and international regulatory requirements
• Experience with quality management systems, deviation investigations, CAPA, and root cause analysis
• Proficiency in Microsoft Office and quality management software (TrackWise, Master Control, or equivalent)
• Technical writing, analytical problem-solving, and clear communication skills
• Ability to conduct internal audits, support regulatory inspections, and work in cleanroom environments