Lead QA Specialist - Documentation Control (8hr days, Monday-Friday)

Work Schedule

Second Shift (Afternoons)

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:

Greenville, NC

How Will You 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

• Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
• Foundational understanding in batch record review, change control and CAPA management
• Advanced proficiency in documentation systems (e.g. eDMS, Documentum)
• 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