QC Specialist III-Stability

Lonza•Portsmouth, NH

1d•Onsite

About The Position

The QC Specialist III – Stability is responsible for managing and executing stability studies within the Quality Control Laboratory. This role supports GMP-compliant stability programs through study setup, sample management, testing coordination, data tracking, and report generation. As a senior-level specialist, this position requires strong technical expertise, sound judgment, and the ability to independently manage moderately complex assignments. The QC Specialist III serves as the primary Stability representative on Analytical Project Teams and works directly with customers, contract laboratories, and internal cross-functional teams. This role also provides mentorship and technical guidance to junior team members while driving compliance, operational excellence, and audit readiness initiatives.

Requirements

Minimum of 4 years of hands-on experience managing or supporting GMP stability programs within a pharmaceutical, biotechnology, or other regulated laboratory environment, including the coordination, tracking, and execution of stability studies
Demonstrated experience setting up stability protocols, maintaining stability sample inventories, coordinating testing activities, and managing stability documentation in compliance with GMP requirements
Working knowledge of aseptic techniques and GMP laboratory practices, with the ability to maintain sample integrity and compliance within a controlled laboratory environment
Strong understanding of GMP regulations, Data Integrity principles, and quality compliance expectations, with the ability to consistently apply them in daily laboratory operations
Excellent written and verbal communication skills, with the ability to effectively communicate with customers, business partners, and cross-functional internal teams
Proven ability to interpret and analyze data, prioritize multiple assignments, solve problems effectively, and make sound decisions in a fast-paced laboratory environment
Strong attention to detail, organizational skills, and a continuous improvement mindset focused on operational efficiency, compliance, and audit readiness initiatives

Responsibilities

Manage and execute GMP stability studies within the QC laboratory
Set up stability protocols, schedules, and sample tracking activities
Perform stability pulls and coordinate shipment of samples to customers and contract labs
Track testing timelines and ensure timely completion of stability studies
Create, review, and revise GMP documentation including protocols, reports, deviations, and change controls
Participate in customer project teams as the Stability representative
Communicate effectively with customers, business partners, and internal departments
Support laboratory investigations and process change activities
Maintain compliance with Data Integrity and GMP requirements
Drive audit readiness activities and support inspections as a subject matter expert (SME)
Mentor, train, and provide guidance to junior team members
Delegate tasks and support daily laboratory operations
Identify and implement process improvements and operational efficiencies
Complete assignments accurately, on time, and with minimal supervision