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

About the role

As a Lead QA Technician, you will play a critical role in ensuring product quality and regulatory compliance within pharmaceutical manufacturing operations. As part of the Quality team, your work directly supports the production of life-changing medicines while enabling Thermo Fisher Scientific's mission of making the world healthier, cleaner, and safer.

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
• Bachelor's degree preferred in Chemistry, Pharmacy, Biology, Biotechnology, or a related scientific discipline; equivalent experience in a GMP-regulated environment will be considered

Experience

• Minimum of 3 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

Knowledge, Skills, and Abilities

• 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

Competencies

• Demonstrates Thermo Fisher Scientific leadership attributes
• Acts as a role model for quality and compliance
• Customer-focused with a continuous improvement mindset
• Accountable, self-directed, and results-oriented
• Effective collaborator and communicator
• Committed to mentoring and developing others