QA Compliance Specialist 2

Katalyst CRO; Portsmouth (NH); Presencial; USD 90.000 - 110.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Portsmouth, NH seeks a QA Specialist QA Compliance to support the site's QMS and ensure alignment with Lonza Group Quality Standards. You lead gap assessments, coordinate remediation, and drive timely changes in procedures while collaborating with Global Quality, Manufacturing, Regulatory Affairs, and others.

The role emphasizes continuous improvement, cGMP compliance, and effective documentation, training, and KPI reporting to sustain high quality across processes.

Formación

• 3-5 years in Quality assurance.
• 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.

Responsabilidades

• 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.

Conocimientos

Quality assurance

Project management

Stakeholder liaison

Planning & organizing

Decision making

Multitasking

Communication

Attention to detail

Safety awareness

Self-motivated

Teamwork

Educación

Bachelor Degree (Life sciences)

Master's degree or equivalent experience (preferred)

Herramientas

Trackwise

SAP

Document management system

Descripción del empleo

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 while driving 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 Degree(Life sciences), Master's degree or equivalent experience(preferred)

Work Experience And Skills

• 3-5 years in Quality assurance
• 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.