QA Specialist

Job Description

Job Description

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.