Lead QA Technician — GMP Aseptic Quality Leader

ThermoFisher Scientific; Greenville (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Lead QA Technician to provide independent quality oversight of GMP manufacturing operations, ensuring product quality and regulatory compliance. You will lead batch record reviews, deviation investigations, and CAPA efforts, while supporting regulatory inspections and audits.

You will use TrackWise and Documentum, mentor QA Technicians, and collaborate with Manufacturing, Validation, Engineering, and Regulatory teams to uphold data integrity and continuous

Qualifications

• High School Diploma or equivalent required.
• Preferred fields of study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field.
• Minimum of three (3) years of experience in pharmaceutical quality assurance or GMP environment; four (4) years preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Responsibilities

• Provide independent quality oversight of GMP manufacturing operations, including aseptic processing.
• Perform and lead batch record review to ensure accuracy and compliance with regulatory and internal requirements.
• Lead and support deviation investigations, root cause analysis, and CAPA development and effectiveness checks.
• Utilize electronic quality systems such as TrackWise and Documentum to manage documentation and workflows.
• Partner with Manufacturing, Validation, Engineering, and Regulatory teams to support compliant operations.
• Support and participate in regulatory inspections, internal audits, and customer audits.
• Apply knowledge of aseptic manufacturing controls, cleanroom operations, and gowning practices.
• Mentor and provide technical guidance to QA Technicians and peers.
• Identify opportunities for continuous improvement and quality system enhancements.
• Ensure compliance with site procedures, safety requirements, and data integrity standards.

Skills

Batch record review

Deviation investigations

CAPA management

Aseptic manufacturing

Regulatory inspections

Cross-functional collaboration

Attention to detail

Analytical problem-solving

Communication skills

Project management

Microsoft Office

Team leadership

Education

High School Diploma or equivalent

Chemistry / Pharmacy / Biology / Biotechnology

Tools

TrackWise

Documentum

Job description

Thermo Fisher Scientific is seeking a Lead QA Technician to provide independent quality oversight of GMP manufacturing operations, ensuring product quality and regulatory compliance. You will lead batch record reviews, deviation investigations, and CAPA efforts, while supporting regulatory inspections and audits.

You will use TrackWise and Documentum, mentor QA Technicians, and collaborate with Manufacturing, Validation, Engineering, and Regulatory teams to uphold data integrity and continuous