QA Compliance Specialist 2

Katalyst-Healthcares-; Portsmouth (NH); On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst-Healthcares is seeking a QA Specialist – QA Compliance to support the site's Quality Management System and ensure alignment with Lonza Group Quality Standards. You will lead gap assessments, coordinate remediation, and work with Global Quality, Manufacturing, Regulatory Affairs, and others to maintain cGMP compliance.

Ideal candidates have a life sciences degree, 3–5 years in QA, strong project management and communication skills, and experience with Trackwise and SAP.

Qualifications

• Bachelor's Degree in Life Sciences required; Master’s preferred.
• 3–5 years in Quality Assurance.
• Experience with TrackWise, SAP, and document management systems.

Responsibilities

• Lead gap assessments of local QMS against Group procedures.
• Coordinate updates to local SOPs and controlled documents.
• Track implementation to defined timelines and drive remediation.
• Partner with process owners to implement compliant solutions.
• Support Change Control, CAPA, Deviations, and QRM activities.
• Assist internal audits and regulatory inspections.
• Monitor KPIs and prepare management reports.

Skills

Project Management

Presentation

Customer Liaison

Meeting Facilitation

Planning

Communication

Adaptability

Decision Making

Detail-Oriented

Teamwork

Education

Bachelor's Degree in Life Sciences

Master's Degree preferred

Tools

TrackWise

SAP

Document Management System

Job description

Job Description

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.