Quality Specialist III, Batch Record Review

Thermo Fisher Scientific • Greenville, NC

15h • Hybrid

About The Position

The Quality Assurance Specialist III – Batch Release plays a critical role in ensuring that manufactured products meet all quality and regulatory requirements prior to release. This position supports site-wide batch disposition activities, with a strong focus on sterile/aseptic manufacturing processes. You will partner cross-functionally to ensure compliance with GMP standards while driving timely and accurate batch review and release.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field required
• Minimum 5 years of Quality Assurance experience in a regulated pharmaceutical environment
• Experience with sterile/aseptic manufacturing and batch release activities
• Strong knowledge of GMP/GxPregulations and quality systems
• Proven experience in batch record review and product disposition
• Familiarity with deviation management, CAPA, and change control processes
• Strong investigation and root cause analysis capabilities
• Excellent attention to detail and documentation skills
• Effective written and verbal communication skills across all levels
• Ability to work both independently and collaboratively in a team environment
• Proficiency with quality systems (e.g., TrackWise) and Microsoft Office

Responsibilities

• Perform comprehensive batch record review to support product release in compliance with GMP and regulatory requirements
• Ensure all documentation, deviations, and investigations are complete, accurate, and aligned with quality standards
• Collaborate with Manufacturing, Quality Control, and other cross-functional teams to resolve batch-related issues
• Evaluate deviations, change controls, and CAPAs for impact on product quality and release decisions
• Support inspection readiness and participate in internal and external audits
• Communicate effectively across all organizational levels to ensure alignment on quality expectations
• Contribute to continuous improvement initiatives within the Quality organization

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level