QA Compliance Specialist 2

Job Title: QA Compliance Specialist ID: 26-03964 Location: Portsmouth, NH Duration: 6 Months Project Summary:

• The QA Specialist QA Compliance is responsible for supporting and maintaining the site's Quality Management System (QMS) by ensuring alignment between local quality procedures and Lonza Group Quality Standards.
• The role leads structured gap assessments of local procedures against Group procedures, identifies compliance gaps, coordinates remediation activities, and ensures timely implementation of required changes.
• The position collaborates with Global Quality, Manufacturing, Quality Operations, Engineering, Regulatory Affairs, and other stakeholders to maintain compliance with corporate standards and applicable GMP regulations and to drive continuous improvement

• Lead gap assessments of local Quality Management System procedures against Group Quality Procedures and Corporate Standards.
• Coordinate updates to local SOPs, work instructions, and controlled documents.
• Track implementation and drive completion to defined timelines.
• Partner with process owners and SMEs to establish and implement compliant solutions.
• Support Change Control, CAPA, Deviations, and Quality Risk Management activities.
• Support internal audits and regulatory inspections.
• Monitor compliance metrics and prepare management reports through trending and visual KPI management.
• Develop and provide training and guidance on new or revised quality procedures.
• Drive continuous improvement and harmonization of Quality System processes.

• Bachelor's degree required; Master's degree or equivalent experience
• 3-5 or more years in GMP environment. Minimum 0-3 years in Quality Assurance or similar discipline. Biotechnology manufacturing background is preferred
• Knowledge of cGMP and regulations
• Project Management Experience: Presentation, Customer Liaison, Meeting facilitation
• Demonstrates flexibility to adapt to changing business priorities. .
• Demonstrates ability for effective Planning, Organizing and Controlling competency.
• Demonstrates sound decision-making, considering broad scope of factors.
• Able to manage multiple priorities and achieve results.
• Good ability to complete assignments under tight timelines and work under pressure.
• Demonstrates knowledge on continuous improvement within the adherence to standardized procedures & cGMP compliance.
• Experience with Trackwise and SAP; document management system preferred.
• Detail-oriented
• Displays a clear willingness to listen to others.
• Self-starter, solid written and verbal communication, good attention to detail, works effectively individually and with teams, positive attitude, customer-focused
• Practices safety awareness at all times.