Thermo Fisher Scientific · 3 days ago
Lead QA Technician
Greenville, NC
Full-time
Onsite
Mid, Senior Level
4+ years expThermo Fisher Scientific is a leading contract development and manufacturing organization focused on making the world healthier, cleaner, and safer. As a Lead QA Technician, you will ensure product quality and regulatory compliance in pharmaceutical manufacturing operations, supporting the production of life-changing medicines.
Research
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
Qualification
Required
Bachelor's degree preferred in Chemistry, Pharmacy, Biology, Biotechnology, or a related scientific discipline, preferred
Equivalent experience in a GMP-regulated environment will be considered
A minimum of 4 years of experience in pharmaceutical quality assurance or a related GMP-regulated manufacturing environment
Demonstrated experience supporting aseptic manufacturing and sterile operations
Experience supporting regulatory inspections and customer audits
Demonstrated ability to work independently with limited supervision in a dynamic environment
Advanced knowledge of GMP regulations, FDA guidance, and pharmaceutical quality systems
Strong expertise in batch record review, deviation management, CAPA, and root cause analysis
Proficiency with electronic quality management systems and documentation platforms
Strong written and verbal communication skills with the ability to effectively collaborate across functions
Excellent attention to detail with strong analytical and problem-solving skills
Ability to manage multiple priorities and adapt to changing production demands
Proficiency with Microsoft Office applications
Ability to work various shifts as required by manufacturing operations
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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