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

Responsibilities

• 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.

Education:

• 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.

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com