Lead QA Technician (8hr days, Monday-Friday)

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

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

How You Will Make an Impact

Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

Shift is Monday-Friday, 8hr days.

A Day in the Life

• 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

Education:

• High School Diploma or equivalent required.
• Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field

Experience

• Minimum of three (3) years of experience in pharmaceutical quality assurance or related GMP environment, four (4) years preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered

Knowledge, Skills, and Abilities

• Expertise in batch record review, deviation investigations and CAPA management
• Strong understanding of aseptic manufacturing processes and controls
• Professional communication skills both written and spoken
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Project management and organizational capabilities
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Ability to work various shifts as required
• Demonstrated ability to guide and develop team members
• Ability to understand and interpret technical procedures and specifications

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.