BioTalent
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.
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.