Job Description

Job Title: Quality Assurance Specialist QMS (TrackWise & Veeva Vault)

Location: Portsmouth, NH (On-site)

Company: BioTalent United States

Introduction

Join a leading biotechnology manufacturing organization in Portsmouth, NH, dedicated to advancing high-quality biopharmaceutical production. We are seeking an experienced Quality Assurance Specialist with a strong background in Quality Management Systems (QMS) specifically TrackWise and Veeva Vault to support our quality operations and compliance initiatives.

This position plays a critical role in ensuring adherence to cGMP standards , maintaining robust quality systems, and driving continuous improvement across manufacturing and quality processes.

This Role Will Offer You

• The opportunity to support and enhance QMS activities within a state-of-the-art biotech manufacturing facility
• A collaborative environment committed to excellence, compliance, and continuous improvement
• Competitive compensation and a comprehensive benefits package
• Professional development opportunities in QMS, regulatory compliance, and biopharmaceutical manufacturing quality systems

You Will Be Responsible For

• Managing and maintaining Quality Management System (QMS) processes using TrackWise and Veeva Vault , including change control, deviations, CAPAs, and document management
• Supporting batch record review, manufacturing floor oversight, and quality documentation to ensure compliance with cGMP and regulatory requirements
• Reviewing, approving, and tracking quality events and ensuring timely closure within QMS platforms
• Assisting in internal and external audits, inspection readiness, and regulatory submissions
• Collaborating cross-functionally with Manufacturing, Quality Control, and Engineering teams to ensure consistent quality standards across production operations
• Generating and maintaining metrics, trend reports, and continuous improvement initiatives related to QMS performance
• Contributing to training programs and ensuring adherence to established SOPs and corporate quality policies

You Will Bring the Following

• Bachelors degree in Life Sciences, Engineering, or a related field (or equivalent experience)
• 35+ years of experience in Quality Assurance within a biotech or pharmaceutical manufacturing environment
• Demonstrated expertise in TrackWise and Veeva Vault QMS platforms
• Strong understanding of cGMP regulations , quality systems, and documentation practices
• Experience supporting investigations, CAPA, change control, and document management processes
• Excellent communication, organizational, and analytical skills with attention to detail
• Ability to work independently and collaboratively in a fast-paced, regulated environment

To learn more or apply, please contact:

📧 devon.nzepuome@biotalent.com

BioTalent Ltd is acting as an employment agency in relation to this opportunity.

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