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QC Specialist III - Stability

Lonza

Portsmouth, NHOnsitePosted 26 days ago
Full TimeMid LevelQuality (QA / QC)CDMO
Original posting ↗

Summary

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.

Job description

This role follows a Monday-Friday, 7:00 AM - 3:30 PM schedule.

What you will do:

  • 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

What we are looking for:

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

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

Benefits

  • Medical, Dental & Vision
  • Career growth opportunities
  • Professional development
  • Collaborative environment

Company overview

Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.

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