QA Compliance Specialist 2

Job Title: QA Compliance Specialist 2 Job Location: Portsmouth, NH Job Duration: 6 Months

• 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 Client 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 while driving 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 or equivalent experience. Preferred area of study: Scientific related field
• 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. .
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate 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, SAP, Document management system preferred.
• Detail-oriented
• Self-motivated
• 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.