Quality Assurance Specialist (Portsmouth)BioTalent • Portsmouth, NH, US
Quality Assurance Specialist (Portsmouth)
BioTalent • Portsmouth, NH, US
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job_description.job_card.job_descriptionManaging 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 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
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
You Will Bring the Following
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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Quality Assurance Specialist • Portsmouth, NH, US
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