Quality Specialist III, Batch Record Review

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

About Thermo Fisher Scientific
As part of the Thermo Fisher Scientific team, you’ll 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 world’s 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

•Bachelor’s 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 Monday–Friday 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.