QA Specialist

Location: Portsmouth, NH

Employment Type: Contract

Job ID: 1463

QA Specialist – GMP Quality Systems / Compliance

Job Description

We are seeking an experienced QA Specialist – GMP Quality Systems / Compliance to support Quality Assurance activities within a regulated biotechnology manufacturing environment in Portsmouth, NH.

This position will support and maintain the site's Quality Management System (QMS), with a strong focus on ensuring local procedures align with corporate Quality Standards and applicable cGMP requirements. The QA Specialist will perform gap assessments, coordinate remediation activities, support quality system processes, and work cross-functionally with Manufacturing, Quality Operations, Engineering, Regulatory Affairs, and other stakeholders.

Key Responsibilities

• Lead gap assessments of local QMS procedures against Group Quality Procedures and corporate standards.
• Coordinate updates to SOPs, work instructions, and controlled documents.
• Track remediation activities and drive completion within established timelines.
• Partner with process owners and SMEs to develop and implement compliant solutions.
• Support Change Controls, CAPAs, Deviations, and Quality Risk Management activities.
• Support internal audits and regulatory inspections.
• Monitor quality/compliance metrics and prepare reports and KPI trends for management.
• Provide training and guidance related to new or revised quality procedures.
• Support continuous improvement and harmonization of Quality System processes.

Qualifications

• Bachelor's degree in Life Sciences or a related scientific field required.
• Master's degree or equivalent experience is preferred.
• 3–5 years of experience in a GMP environment.
• Quality Assurance or similar quality experience.
• Biotechnology manufacturing experience preferred.
• Strong knowledge of cGMP requirements and regulations.
• Experience supporting Quality Management Systems.
• Project management experience, including presentations, meeting facilitation, and stakeholder coordination.
• Ability to manage multiple priorities and deliver results under tight timelines.
• Strong written and verbal communication skills.
• Detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams.
• Experience with TrackWise, SAP, and/or document management systems preferred.