QC Specialist II-Stability

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

Requirements

• 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
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

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. What you will get: Below you will find a comprehensive summary of the benefits package we offer: 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.

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