QA Compliance Specialist 2

This role leads structured gap assessments of local procedures against Group procedures, identifies compliance gaps, coordinates remediation activities, and ensures timely implementation of required changes. Driving Results: Proactively identify gaps, address issues, and implement improvements to streamline workflows.

QA Compliance Specialist 2
Location: 101 International Drive, Portsmouth, NH 03801
Contract Duration: 6 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $72.99–$86.26/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance
 
Job Summary
The QA Compliance Specialist 2 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. This 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 works closely with Global Quality, Manufacturing, Quality Operations, Engineering, Regulatory Affairs, and other cross-functional stakeholders to maintain compliance with corporate standards and applicable GMP regulations while supporting continuous improvement initiatives.
 
Key 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 activities and drive completion within established timelines.
• Partner with process owners and subject matter experts to develop 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 data trending and KPI visualization.
• Develop and deliver training and guidance on new or revised quality procedures.
• Drive continuous improvement and harmonization of Quality System processes.

 
Qualifications
Education

• Bachelor’s degree required, preferably in Life Sciences or a related scientific field.
• Master’s degree or equivalent experience in Business, Engineering, or a related field is preferred.
• Business-fluent English proficiency, both written and spoken.

 
Experience

• 3–5 years of experience in Quality Assurance.
• 3–5 or more years of experience working in a GMP environment.
• Experience in CGT/biotechnology manufacturing is preferred.
• Knowledge of cGMP requirements and applicable regulations.
• Experience supporting Quality Assurance or a similar quality discipline.

 
Required Skills

• Strong knowledge of cGMP and regulatory requirements.
• Experience with Quality Management Systems and compliance activities.
• Project management experience, including presentations, customer/stakeholder liaison, and meeting facilitation.
• Ability to manage multiple priorities and deliver results under tight timelines.
• Strong planning, organization, and execution skills.
• Sound decision-making and problem-solving abilities.
• Ability to adapt quickly to changing business priorities.
• Experience with continuous improvement while maintaining standardized procedures and cGMP compliance.
• Experience with TrackWise, SAP, and document management systems is preferred.
• Strong written and verbal communication skills.
• Excellent attention to detail.
• Self-motivated and proactive with the ability to work independently and collaboratively.
• Strong stakeholder management and customer-focused approach.

 
Core Competencies

• Agility: Ability to adapt to changing priorities, support cross-functional initiatives, and recommend improvements for identified compliance concerns.
• Business Acumen: Ability to communicate status, risks, needs, forecasts, and timelines effectively to management.
• Collaboration: Ability to work effectively with cross-functional teams while managing competing priorities and deadlines.
• Customer Focus: Ability to communicate information clearly and professionally with stakeholders.
• Driving Results: Proactively identify gaps, address issues, and implement improvements to streamline workflows.
• Leadership: Demonstrate accountability, ownership, and clear two-way communication across teams.

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