QC Specialist II-Stability

QC Specialist II–Stability

Location:

This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 7:00 AM–4:00 PM EST.

• Performance‑related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short‑term and long‑term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

The QC Specialist II – 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.

• 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

• Minimum of 3 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

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.