Quality Assurance Specialist

Job Title: Quality Assurance Specialist – QMS (TrackWise & Veeva Vault)Location: Portsmouth, NH (On-site) Company: BioTalent · United StatesIntroductionJoin 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 YouThe opportunity to support and enhance QMS activities within a state-of-the-art biotech manufacturing facilityA collaborative environment committed to excellence, compliance, and continuous improvementCompetitive compensation and a comprehensive benefits packageProfessional development opportunities in QMS, regulatory compliance, and biopharmaceutical manufacturing quality systemsYou Will Be Responsible ForManaging and maintaining Quality Management System (QMS) processes using TrackWise and Veeva Vault, including change control, deviations, CAPAs, and document managementSupporting batch record review, manufacturing floor oversight, and quality documentation to ensure compliance with cGMP and regulatory requirementsReviewing, approving, and tracking quality events and ensuring timely closure within QMS platformsAssisting in internal and external audits, inspection readiness, and regulatory submissionsCollaborating cross-functionally with Manufacturing, Quality Control, and Engineering teams to ensure consistent quality standards across production operationsGenerating and maintaining metrics, trend reports, and continuous improvement initiatives related to QMS performanceContributing to training programs and ensuring adherence to established SOPs and corporate quality policiesYou Will Bring the FollowingBachelor’s degree in Life Sciences, Engineering, or a related field (or equivalent experience)3–5+ years of experience in Quality Assurance within a biotech or pharmaceutical manufacturing environmentDemonstrated expertise in TrackWise and Veeva Vault QMS platformsStrong understanding of cGMP regulations, quality systems, and documentation practicesExperience supporting investigations, CAPA, change control, and document management processesExcellent communication, organizational, and analytical skills with attention to detailAbility to work independently and collaboratively in a fast-paced, regulated environmentTo learn more or apply, please contact: 📧 devon.nzepuome@biotalent.comBioTalent Ltd is acting as an employment agency in relation to this opportunity.