QC Specialist III-Stability

Lonza•Portsmouth, NH

2d•Onsite

About The Position

As a QC Specialist III - Stability, you will play a critical role in supporting the delivery of life-changing therapies through the management of stability programs in a GMP environment. This is an excellent opportunity to take ownership of stability studies from setup through final reporting while partnering with customers and collaborating across Quality, Program Management, and Operations teams.

Requirements

Experience managing stability studies within a GMP-regulated pharmaceutical, biotechnology, or related industry
Strong knowledge of stability protocols, reports, controlled documentation, and quality systems
Ability to build relationships and communicate effectively with customers and cross-functional teams
Experience coordinating multiple priorities and delivering results in a fast-paced environment
Demonstrated problem-solving skills and the ability to work independently
Associate's or Bachelor's degree in Life Sciences or a related field, or equivalent combination of education and experience

Nice To Haves

Experience in Quality Control, Stability, or other regulated laboratory environments preferred

Responsibilities

Manage stability studies from setup through completion, ensuring quality, compliance, and timely delivery
Partner with customers as a primary stability contact and provide updates throughout the study lifecycle
Develop, review, and maintain stability protocols, reports, and GMP documentation
Coordinate testing activities, sample management, and study timelines with internal and external partners
Collaborate with QC, QA, Program Management, and Operations teams to support customer programs
Support investigations, change controls, and continuous improvement initiatives
Mentor colleagues and contribute to the development of stability best practices across the organization