Quality Specialist III, Batch Record Review

Work Schedule

Environmental Conditions

Job Description

About Thermo Fisher Scientific
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier cleaner and safer. We support our colleagues with the resources needed to achieve individual career goals while advancing solutions to some of the worlds toughest challenges.

About the Business
Our Pharma Services Group (PSG) is a global leader in integrated drug development and manufacturing solutions for pharmaceutical and biotech companies. The Greenville NC site specializes in sterile and oral solid dose (OSD) manufacturing supported by advanced technologies and a collaborative quality-focused environment.

Discover Impactful Work
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.

A Day in the Life

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

Keys to Success

Education & Experience

Bachelors degree in Life Sciences Chemistry Engineering or related field required

Minimum 5 years of Quality Assurance experience in a regulated pharmaceutical environment

Required: Experience with sterile/aseptic manufacturing and batch release activities

Knowledge Skills & Abilities

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

Working Conditions

Standard MondayFriday business hours

Work performed in both office and manufacturing environments requiring appropriate PPE

Why Join Us
You will be part of a high-performing Quality team supporting critical pharmaceutical manufacturing operations. This role offers the opportunity to directly impact patient safety and product quality while working in a collaborative and growth-oriented environment.