Quality Specialist III, Batch Record Review
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
The 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.
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/GxP regulations 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.