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

Thermo Fisher Scientific•Greenville, NC

9h•Onsite

About The Position

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

Requirements

High School Diploma or equivalent required.
Minimum of three (3) years of experience in pharmaceutical quality assurance or related GMP environment, four (4) years preferred.
E quivalent combinations of education, training, and relevant work experience may be considered
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

Nice To Haves

Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field

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