Quality Specialist III, Batch Record Review

ThermoFisher Scientific is hiring a Quality Specialist III, Batch Record Review in Greenville, Pitt County. This full-time position offers the chance to ensure product excellence and regulatory compliance at a company that enables discovery and innovation across life sciences, diagnostics, and applied markets worldwide.

About the Role

As a Quality Specialist III focused on batch record review, you'll serve as a critical quality control function within our manufacturing operations. Your expertise in documentation review, process validation, and regulatory standards will directly impact the safety and efficacy of products that serve millions of customers globally. This role combines meticulous attention to detail with technical knowledge of manufacturing processes and quality systems.

What You'll Do

• Conduct comprehensive review of batch production records, including raw materials, process parameters, testing results, and packaging records
• Verify compliance with standard operating procedures, specifications, and regulatory requirements such as FDA guidelines and cGMP standards
• Identify discrepancies, deviations, and areas of non-conformance, documenting findings and recommending corrective actions
• Collaborate with manufacturing, engineering, and quality assurance teams to resolve batch-related issues
• Maintain detailed records and prepare quality documentation required for internal audits and regulatory inspections
• Support continuous improvement initiatives and contribute to quality metrics and performance tracking

What We're Looking For

• Bachelor's degree in life sciences, chemistry, pharmaceutical sciences, biology, or related field, or equivalent experience in a regulated manufacturing environment
• 3+ years of quality assurance, quality control, or batch record review experience in pharmaceutical, biotech, or medical device manufacturing
• Deep knowledge of FDA regulations, cGMP requirements, and quality systems in regulated industries
• Strong analytical and documentation skills with meticulous attention to detail
• Ability to lift up to 40 pounds without assistance and work in an office/lab environment requiring personal protective equipment including safety glasses, gowning, gloves, lab coat, and ear protection
• Proficiency with quality management systems (QMS) and batch record software
• Excellent communication skills and ability to work effectively across functional teams
• First-shift availability (day schedule, Monday-Friday)

About ThermoFisher Scientific

ThermoFisher Scientific is the world leader in serving science. With annual revenues exceeding $40 billion, we provide customers with innovative solutions across research, clinical diagnostics, bioproduction, and laboratory services. Our mission is to enable our customers to make the world healthier, cleaner, and safer.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.